SOLE AGENT/ DISTRIBUTOR

CERTIFICATE OF PRODUCTION
CERTIFICATE OF DISTRIBUTION (PAK)
ADDRESS
PHONE/ FAX. / E-MAIL

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:
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PT. Jayamas Medica Industri

HK.07.Alkes/V/010/AK.1/2011
HK.07.Alkes/IV/250/AK.2/2012
Jl. By Pass KM. 28, Sidomojo, Krian, Sidoarjo, Jawa Timur
031 8982349, 8985269 / 031 8985268 / uus@onemed.co.id

NAME OF PRODUCT
BRAND / MANUFACTURER
MODEL / TYPE
COUNTRY OF ORIGIN
FACTORY OF ORIGIN
OUTSOURCE EXTERNAL MANUFACTURE (OEM)
PRODUCT'S REGISTRATION (AKL/AKD)
PRODUCT'S CERTIFICATION
FDA Clearance
Certificate ISO 9001 : 2008
Certificate ISO EN 13485 : 2012
Indonesian GMP ( CPAKB )
Locally Content (Tingkat Komponen Dalam Negeri)
WHERE MARKETED
REFERENCE OF TECHNICAL
Material
Squeeze bag, mask
Reservoir bag
Squeeze bag volume
Stroke Volume
Reservoir volume
Minimum cycle rate
Oxygen concentration
Maximum Pressure Relief
Manometer Range
Peak Inspiratory Pressure (PIP)
Positive-end expiratory
Gas Inlet flow range
Delivered oxygen concentration
Operating time (400 L cylinder)
*) Example : Delivery Time, Capacity of Production, Price,
OTHER
INFORMATIONS
*)
Commitment
of Maintenance,
Warranty, Discontinue/Life
Time Medical Device, etc.

ayamas Medica Industri

07.Alkes/V/010/AK.1/2011
07.Alkes/IV/250/AK.2/2012
y Pass KM. 28, Sidomojo, Krian, Sidoarjo, Jawa Timur
8982349, 8985269 / 031 8985268 / uus@onemed.co.id
INFANT RESUSCITATOR
BESMED
MANUAL / SILICONE
INDONESIA
INDONESIA
Kemenkes RI AKD 200403900264

OK
OK
OK
approx 40%
INDONESIA

Medical grade Silicone

Medical grade PVC
280 ml
150 ml
500 ml
40 breaths/min
90%
40 5 cmH2O
-

autoclavable