Identity
- Trade Name
- ASEPT® FDA UDI
- Generic Name
- Closed-wound drainage kit FDA UDI
- Device Name
- ASEPT 600ML BOTTLE W/O DRAIN LINE FDA UDI
- Model / Reference
- 622272 FDA UDI
- Description
- ASEPT 600ML BOTTLE W/O DRAIN LINE FDA UDI
Identifiers
- Catalog Number
- 622272 FDA UDI
- Primary DI / UDI-DI
- 04046964317101 FDA UDI
- 510(k) Number
- K001716 FDA UDI
- FDA Product Code
- JCX FDA UDI
- GMDN Term
- Closed-wound drainage kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
Yes
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
No
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 — 600.0 Milliliter FDA UDI
Asept® by B Braun Interventional Systems, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K001716 also covers:
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- B Braun Interventional Systems, Inc
Sources (1)
- FDA UDI 11982ee6-fdb6-459c-9179-e4b32ea402a7 39 fields · synced Jun 1, 2026