Identity
- Trade Name
- Eakin FDA UDI
- Generic Name
- Wound drainage bag FDA UDI
- Device Name
- Eakin access window FDA UDI
- Model / Reference
- 839280 FDA UDI
- Description
- Eakin access window FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00768455126859 FDA UDI
- FDA Product Code
- FON FDA UDI
- GMDN Term
- Wound drainage bag 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Wound drainage bag
Eakin by T.g. Eakin Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound drainage bag.
- Hollister — Hollister Incorporated · Class I
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- Hollister — Hollister Incorporated · Class I
- Hollister — Hollister Incorporated · Class I
- ASEPT® — B BRAUN INTERVENTIONAL SYSTEMS, INC · Class I
- Hollister — Hollister Incorporated · Class I
- Eakin — T.G. EAKIN LIMITED · Class I
- Eakin — T.G. EAKIN LIMITED · Class I
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
- T.g. Eakin Limited
Sources (1)
- FDA UDI 71e120dd-dfab-4a42-83e1-d2123235cd87 35 fields · synced May 31, 2026