Identity
- Trade Name
- ASEPT® FDA UDI
- Generic Name
- Wound drainage bag FDA UDI
- Device Name
- 2,000 ML ASEPT DRAINAGE BAG FDA UDI
- Model / Reference
- 622280 FDA UDI
- Description
- 2,000 ML ASEPT DRAINAGE BAG FDA UDI
Identifiers
- Catalog Number
- 622280 FDA UDI
- Primary DI / UDI-DI
- 04046964317255 FDA UDI
- FDA Product Code
- FMH FDA UDI
- GMDN Term
- Wound drainage bag FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.3250 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 2000.0 Milliliter FDA UDI
Category: Wound drainage bag
Asept® by B Braun Interventional Systems, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Wound drainage bag.
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- Eakin — T.G. EAKIN LIMITED · Class I
- Eakin — T.G. EAKIN LIMITED · 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
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI 5e061116-47f9-4018-9279-193b29a8f73c 37 fields · synced May 30, 2026