FDA UDI
In Commercial Distribution
🇺🇸 United States
EMI
DI: 06946430414366
·
Model: CP641000+2A+PG
·
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EMI
- Primary DI
- 06946430414366
- Version / Model
- CP641000+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
- 2022-11-15
- Public Version
- 1
- Public Version Date
- 2022-11-23
- Public Version Status
- New
- Public Device Record Key
- 4b0f3c38-c86d-42c4-a8b3-27c64a43c2e6
Device Description
The cardiopulmonary resuscitation aid kit comprises of one CPR mask with Oxygen Port, two pieces alcohol pads and one pair PVC glove. This kit is designed for mouth to mask ventilation to health emergency patients requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques of a non-breathing patient. It functions as a barrier to direct expired air from the patient away from the user. It can be used with supplemental oxygen when needed.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- 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
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OEV | Cardiopulmonary Resuscitation Aid Kit | Anesthesiology | 868.5915 | 2 |
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., emergency pharmaceuticals, airway tubes, face masks or resuscitator). It is typically placed in a convenient location in public buildings and in 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 | 16946430414363 | GS1 | carton | 60 | In Commercial Distribution | |
| Primary | 06946430414366 | GS1 |