FDA UDI In Commercial Distribution 🇺🇸 United States

Compower

DI: 06946430400390 · Model: CP641002+2A+PG · XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
Compower
Primary DI
06946430400390
Version / Model
CP641002+2A+PG
Company Name
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Labeler DUNS
543482946
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2018-02-28
Public Version
2
Public Version Date
2019-08-21
Public Version Status
Update
Public Device Record Key
e39f1c6a-e09b-4217-b2f1-2107b495cd2d

Device Description

The cardiopulmonary resuscitation aid kit comprises of one CPR Mask without Oxygen Port, two pieces alcohol pad and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring cardiopulmonary resuscitator (CPR) rescue techniques of a non-breathing patient. It also functions as a barrier that will direct expired air from the patient away from the user.

Device Characteristics

Single Use
Yes
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
Yes
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

GMDN Terms

Code Name
35693 Cardiopulmonary resuscitation kit, single-use

Identifiers

Type ID
Package 16946430400397
Primary 06946430400390