Lot 7

Nasal oxygen mask for oxygen administration, with connecting tube.

(I was thinking about 11304 for child and the other models in this range, and for infant I
was thinking model 13401 and the others in the range)

Specifications YES/NO
Material: PVC for medical use, non-toxic, non-toxic, transparent, without latex and
DEHP.
The nose piece should have anatomical curvature, be soft and flexible, with a smooth
surface and rounded edges, so as not to cause injuries. At the ends to have the shape
of a funnel, for good fixing and sealing.
Clamping system around the patient's head and sliding length regulator.
Connecting tube of at least 210 cm
- with star-shaped lumen to prevent occlusion
- 6mm universal connector at the proximal end for quick connection to the oxygen
source.
With a design that allows an oxygen flow of up to 15 L / min
Available in sizes: neonatal, infant, pediatric, adult YES
Disposable YES
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method, dimensions,
manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece

Lot 8

Mask for oxygen administration with high concentration, with oxygen tank and
connecting tube (Model 30124 for adult).

Specifications YES/NO
Material: PVC for medical use, non-toxic, non-toxic, transparent, without latex
and DEHP.
Specially designed to fit comfortably on the patient's mouth, soft, light and
flexible, with a rounded edge and bent outwards, so as not to cause injury.
Equipped with expiratory holes on the sides and a metal clip for modeling the
shape of the nose.
Clamping system around the patient's head with adjustable elastic band.
I know the
standard one is
With pre-assembled oxygen tank, 2500 ml, with unidirectional valve.
of 1500 mL, can
it be changed?
Connecting tube of at least 210 cm
- with star-shaped lumen to prevent occlusion
- 6mm universal connector at the proximal end for quick connection to the
oxygen source.
Available in the following sizes: infant, pediatric, adult YES
Disposable
Individual packaging.
Sterile packaged product
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
 Price per piece

Lot 11

Simple oxygen mask, for medium concentration oxygen administration, with connecting
tube (I was thinking about model 30122 for adult).

Specifications YES/NO
Material: PVC for medical use, non-toxic, non-toxic, transparent, without latex
and DEHP.
Specially designed to fit comfortably on the patient's mouth, soft, light and
flexible, with a rounded edge and bent outwards, so as not to cause injury.
Equipped with expiratory holes on the sides and a metal clip for modeling the
YES
shape of the nose.
Clamping system around the patient's head with adjustable elastic band.
Connecting tube of at least 210 cm
- with star-shaped lumen to prevent occlusion
- 6mm universal connector at the proximal end for quick connection to the
oxygen source.
To be available in the following sizes: infant, pediatric, adult. YES
Disposable.
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece

Lot 13

Tracheostomy mask for oxygen administration, with connecting tube (Model 30164 for
adult).

Specifications YES/NO
Material: PVC for medical use, Polypropylene, non-toxic, non-toxic,
transparent, without latex and DEHP.
To be equipped with a connector
- able to rotate 360 ° rotating for patient comfort
-18F / 22M
- with an exhalation port for expiration or aspiration.
With soft and rounded edges, so as not to cause injuries.
Clamping system around the patient's head with adjustable elastic band.
Can be used with a nebulizer.
Connecting tube of at least 210 cm
- with star-shaped lumen to prevent occlusion
- 6mm universal connector at the proximal end for quick connection to the
oxygen source.
Available in the following sizes: pediatric, adult. YES
Disposable
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece
Lot 14

Oxygen tent for neonatal (Model 30190)

Specifications YES/NO
Reusable
The product should be completely transparent, to allow the patient to be
YES
viewed from any angle.
To have rounded edges to prevent injuries and a soft silicone collar, delicate
with the skin.
To have optimal weight and to be able to adjust, for neonatal, infant or
pediatric patients, without losing tightness.
Equipped with oxygen diffuser, for uniform oxygen distribution
At its base it has access channels for sensors or IV lines.
Above to present an access port with silicone diaphragm, for probes.
Individual packaging.
Sterile packaged product.
- Packaging and labeling according to EU-MDD (EU Medical Device
Directive) (product name, description, code, validity, batch, sterilization
method, dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece

Lot 15
Simple oxygen mask, for high concentration oxygen administration, with nebulization container
and connecting tube (I was thinking about model 30152).

Specifications YES/NO
Material: PVC for medical use, non-toxic, non-toxic, transparent, without latex
and DEHP.
Specially designed to fit comfortably on the patient's mouth, soft, light and
flexible, with a rounded edge and bent outwards, so as not to cause injury.
Equipped with expiratory holes on the sides and a metal clip for modeling the
shape of the nose.
Clamping system around the patient's head with adjustable elastic band.
With nebulizer container (6ml, 10ml or 20ml, to suit several types of aerosol
therapies) pre-assembled, graduated to each ml.
The design allows the same nebulization efficiency and at angles of up to 90 °,
for patients positioned horizontally.
The minimum atomization rate should be 0.6 ml / min at an average flow rate
of 8 L / min.
The size of the nebulized particles should be at most 4 μm, for maximum
efficiency.
The residual volume of drugs after nebulization should be a maximum of 5%.
Connecting tube of at least 210 cm
- with star-shaped lumen to prevent occlusion
- 6mm universal connector at the proximal end for quick connection to the
oxygen source.
Available in the following sizes: infant, children, adult S, adult M, adult L,
adult XL.
Disposable.
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece
Lot 20

NIV/CPAP mouth-nasal mask

Specifications YES/NO
The body of the mask should be made of flexible, transparent PC.
The mask sleeve should be double, made of soft liquid silicone for medical use
for optimal comfort and sealing.
Fixing it with a neoprene harness in four points arranged laterally.
Fixing / detaching the mask to operate quickly and easily with the help of the 2
hook-shaped connectors of the harness.
The connector should be 22M elbow type, double rotating for patient comfort.
It must be equipped with two 4.3 mm multifunctional ports with a cover, for
CO2 sampling, pressure monitoring or the administration of additional gases.
With 3 types of connector: NIV, CPAP, CPAP with expiration valve.
Reusable product, autoclavable at 134 ° C.
Can be reused up to 40 times.
Available sizes: S, M, L.
Must comply with ISO-10993: 1997 for biocompatibility.
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
I was not able to find an model that is completly compliant with these specs. I
only identified model 13511, 13512, 13513. Please tell me if the product I
suggested is compliant.
Price per piece

Lot 63
Mask for anesthesia and ventilation, with inflatable pillow, single use (I was thinking about
model 20350 for neonatal and the other codes for the other sizes).

Specifications YES/NO
The mask dome and the fixing ring should be made of polycarbonate, for
resistance. The pillow should be made of soft, medical PVC. Do not contain
phthalates or latex.
Transparent mask body, with anatomical shape, perfectly adaptable to the face.
Soft inflatable pillow, takes the shape of the face, for perfect adaptability on
the patient's face and optimal tightness, without causing injuries.
Equipped with unidirectional inflation valve.
The dome of the mask should have streaks to prevent slipping.
Polycarbonate ring, with 4 hooks, colored according to size.
Can be used safely on MRI.
- Dimensions:
• Newborns, Infants - 15 mm OD connector;
• Pediatric, Small Adult, Medium Adult, Large Adult, Extra Large Adult - 22
mm OD connector
Individual packaging.
Sterile packaged product.
Packaging and labeling according to EU-MDD (EU Medical Device Directive)
(product name, description, code, validity, batch, sterilization method,
dimensions, manufacturer's address, etc.). CE mark.
Are the specifications compliant with the model I proposed?
Price per piece
Lot 265

Full face mask (I was thinking about the model 13811 for small, and the others for
meium and large.)

Specifications YES/NO
Head gear
Ventilation circuit connection piece (elbow)
Mask indicated for patients with indication for noninvasive ventilation
With full coverage of the patient's face
It can be easily mounted
No direct contact with the base of the patient's nose to exclude the possibility
of pressure sores on the nose;
No single points of support;
It can be used in patients with facial abnormalities, beard or mustache,
dentition or jaw problems;
Able to allow the efficient elimination of CO2 in case of using a single branch
circuit as follows:
- elbow without any leakage hole, for use with 2-branch circuit (inhale-exhale);
- elbow without any leak hole but with the possibility of connecting a
nebulizer, for use with a 2-branch circuit (inhale-exhale);
- elbow with leak hole no. 2, for use with a single branch circuit.
At least 5 sizes available
Reusable, sterilizable mask for use in multiple patients;
It can be thermally, chemically, gas / plasma sterilized and autoclaved;
Adjustable fastening system, easy to use;
Are the specifications compliant with the model I proposed?
Price per piece