FDA UDI
In Commercial Distribution
🇺🇸 United States
WNLProducts
DI: 06946430419903
·
Model: CP641002+1A+NG
·
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- WNLProducts
- Primary DI
- 06946430419903
- Version / Model
- CP641002+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
- 2024-06-30
- Public Version
- 1
- Public Version Date
- 2024-07-08
- Public Version Status
- New
- Public Device Record Key
- 3f5b4621-db4e-482e-9e48-cae717d38e71
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. It is intended for over the counter use.
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 | Definition | Implantable | Status |
|---|---|---|---|---|
| 35693 | Cardiopulmonary resuscitation kit, single-use | A collection of items in a portable case intended for cardiopulmonary resuscitation (e.g., airway tubes, face masks, resuscitator). It is typically placed in a convenient location in public buildings and in emergency medical services (EMS) vehicles for quick access in emergency situations. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16946430419900 | GS1 | carton | 50 | In Commercial Distribution | |
| Primary | 06946430419903 | GS1 |
Customer Contacts
- Phone
- 800-884-9629
- [email protected]