Identity
- Trade Name
- B.BRAUN FDA UDI
- Generic Name
- Apheresis kit FDA UDI
- Device Name
- EMPTY BAG CONNECTION LINE (US) FDA UDI
- Model / Reference
- 7210934 FDA UDI
- Description
- EMPTY BAG CONNECTION LINE (US) FDA UDI
Identifiers
- Catalog Number
- 7210934 FDA UDI
- Primary DI / UDI-DI
- 04046963847418 FDA UDI
- PMA Number
- P940016 FDA UDI
- FDA Product Code
- MMY FDA UDI
- GMDN Term
- Apheresis kit FDA UDI
Classification
- Device Class
- Class III 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
No
FDA UDI
Category: Apheresis kit
B.braun by B.Braun Avitum AG — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Apheresis kit.
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- Rika Plasma Bottle — Terumo BCT, Inc.. · Class II
- PowerFlow — Bard Access Systems, Inc. · Class II
- Rika Plasma Separation Set — Terumo BCT, Inc.. · Class II
- H.E.L.P.® — B.Braun Avitum AG · Class III
Cleared under the same submission
P940016 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 III | Pending data |
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Manufacturer
- Manufacturer
- B.Braun Avitum AG
Sources (1)
- FDA UDI 75deb9d2-5de2-4e80-8807-9f02ba02898d 37 fields · synced May 31, 2026