Identity
- Trade Name
- AWI FDA UDI
- Generic Name
- Closed-wound/centesis drainage receptacle FDA UDI
- Device Name
- EXTREMITY IRRIGATION BAG FDA UDI
- Model / Reference
- 210-05 FDA UDI
- Description
- EXTREMITY IRRIGATION BAG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06957277200401 FDA UDI
- FDA Product Code
- FON FDA UDI
- GMDN Term
- Closed-wound/centesis drainage receptacle FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Closed-wound/centesis drainage receptacle
Awi by Apex (Guangzhou) Tools & Orthopedics Co. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Closed-wound/centesis drainage receptacle.
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- Thoracentesis and Paracentesis Set — Merit Medical Systems, Inc. · Class I
- One-Step™ — Merit Medical Systems, Inc. · Class I
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
- Merit Medical® — Merit Medical Systems, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Apex (Guangzhou) Tools & Orthopedics Co.
Sources (1)
- FDA UDI fd16bd28-91b6-4b85-b881-767ee44b07ef 33 fields · synced Jun 12, 2026