Identity
- Trade Name
- Volumat™ Line FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Model / Reference
- VL SP 22-0 FDA UDI
Identifiers
- Catalog Number
- M46443160 FDA UDI
- Primary DI / UDI-DI
- 04250273714180 FDA UDI
- FDA Product Code
- FRN FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Blood transfusion set, non-exchange
Volumat™ Line by Fresenius Kabi — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion set, non-exchange.
- Blood Administration Set — Merit Pharmaceutical · Class II
- Walrus — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
- Blood Administration Set — B. BRAUN MEDICAL INC. · Class II
- ICU Medical — ICU MEDICAL, INC. · Class II
- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
Cleared under the same submission
K121613 also covers:
- AGILIA USB CABLE US — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- Secondary Line — Fresenius Kabi
- VOLUMAT MC AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Vigilant Drug'Lib AGILIA US — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
K220301 also covers:
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
- Volumat™ Line — Fresenius Kabi
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
- Fresenius Kabi
Sources (1)
- FDA UDI 456f2a88-1e4e-41f4-b1d8-3927ee82722b 35 fields · synced Jun 8, 2026