Identity
- Trade Name
- PowerFlow FDA UDI
- Generic Name
- Apheresis kit FDA UDI
- Device Name
- PowerFlow IV Port Access System, 16G FDA UDI
- Model / Reference
- AIV16 FDA UDI
- Description
- PowerFlow IV Port Access System, 16G FDA UDI
Identifiers
- Catalog Number
- AIV16 FDA UDI
- Primary DI / UDI-DI
- 00801741136641 FDA UDI
- FDA Product Code
- PTD FDA UDI
- GMDN Term
- Apheresis kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5965 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
Yes
FDA UDI
Combination Product
Yes
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
- Length — 1.77 Inch FDA UDINeedle Gauge — 16 Gauge FDA UDI
Category: Apheresis kit
PowerFlow by Bard Access Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- PowerFlow, ChronoFlex — Bard Access Systems, Inc. · Class II
- PowerFlow — Bard Access Systems, Inc. · Class II
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 |
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Manufacturer
- Manufacturer
- Bard Access Systems, Inc.
Sources (1)
- FDA UDI da257840-1dbd-42b1-8072-d6fa5a2e3a7d 37 fields · synced Jun 9, 2026