FDA UDI
In Commercial Distribution
🇺🇸 United States
Compower
DI: 06946430423719
·
Model: Z40/Z50/Z60/Z70/Z80/Z90/Z100/Z110
·
XIAMEN COMPOWER MEDICAL TECH. CO., LTD
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Compower
- Primary DI
- 06946430423719
- Version / Model
- Z40/Z50/Z60/Z70/Z80/Z90/Z100/Z110
- 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
- 2025-06-27
- Public Version
- 1
- Public Version Date
- 2025-07-07
- Public Version Status
- New
- Public Device Record Key
- 19c8d1aa-838c-4848-8130-c08cd386bceb
Device Description
Berman airway is used to establish the airway and prevent the tongue fall and the airway block.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| CAE | Airway, Oropharyngeal, Anesthesiology | Anesthesiology | 868.5110 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42424 | Oropharyngeal airway, single-use | A curved metal or plastic tube inserted through the mouth to facilitate airway patency for gas exchange or suctioning. The device prevents the tongue from obstructing airflow. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 16946430423716 | GS1 | carton | 70 | In Commercial Distribution | |
| Primary | 06946430423719 | GS1 |