FDA UDI In Commercial Distribution 🇺🇸 United States

ODRESCUE

DI: 06946430421500 · Model: CP641000+1A+NG · XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

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Basic Information

Brand Name
ODRESCUE
Primary DI
06946430421500
Version / Model
CP641000+1A+NG
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
2024-09-01
Public Version
1
Public Version Date
2024-09-09
Public Version Status
New
Public Device Record Key
cbaefb5c-3a45-499a-a002-5ba36693e98b

Device Description

CPR Mask 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)
Yes
Over the Counter (OTC)
No
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
Primary 06946430421500
Package 16946430421507