SOLE AGENT/ DISTRIBUTOR : PT.

Jayamas Medica Industri

CERTIFICATE OF PRODUCTION : HK.07.Alkes/V/010/AK.1/2011
CERTIFICATE OF DISTRIBUTION (PAK) : HK.07.Alkes/IV/250/AK.2/2012
ADDRESS : Jl. By Pass KM. 28, Sidomojo, Krian, Sidoarjo, Jawa Timur
PHONE/ FAX. / E-MAIL : 031 8982349, 8985269 / 031 8985268 / ivana@onemed.co.id

NAME OF PRODUCT INFANT RESUSCITATOR

BRAND / MANUFACTURER BESMED
MODEL / TYPE MANUAL / SILICONE
COUNTRY OF ORIGIN INDONESIA
FACTORY OF ORIGIN INDONESIA
OUTSOURCE EXTERNAL MANUFACTURE (OEM)
PRODUCT'S REGISTRATION (AKL/AKD) Kemenkes RI AKD 200403900264
PRODUCT'S CERTIFICATION
FDA Clearance
Certificate ISO 9001 : 2008 OK
Certificate ISO EN 13485 : 2012 OK
Indonesian GMP ( CPAKB ) OK
Locally Content (Tingkat Komponen Dalam Negeri) approx 40%
WHERE MARKETED INDONESIA
REFERENCE OF TECHNICAL
Material
Squeeze bag, mask Medical grade Silicone
Reservoir bag Medical grade PVC
Squeeze bag volume 280 ml
Stroke Volume 150 ml
Reservoir volume 500 ml
Minimum cycle rate 40 breaths/min
Oxygen concentration
with reservoir 99%
without reservoir 90%
Pressure Relief Valve 40 ± 5 cmH2O
Manometer Range -
Peak Inspiratory Pressure (PIP)
Positive-end expiratory
Gas Inlet flow range
Delivered oxygen concentration
Operating time (400 L cylinder)
OTHER
*) INFORMATIONS
Example *) Capacity of Production, Price,
: Delivery Time, autoclavable
Commitment of Maintenance, Warranty, Discontinue/Life