Identity
- Trade Name
- BD FACSFlow FDA UDI
- Generic Name
- Full blood count IVD, reagent FDA UDI
- Device Name
- BD FACSFlow™ Sheath Fluid FDA UDI
- Model / Reference
- 342003 FDA UDI
- Description
- BD FACSFlow™ Sheath Fluid FDA UDI
Identifiers
- Catalog Number
- 342003 FDA UDI
- Primary DI / UDI-DI
- 00382903420032 FDA UDI
- FDA Product Code
- PPM FDA UDI
- GMDN Term
- Full blood count IVD, reagent FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Category: Full blood count IVD, reagent
BD FACSFlow by Becton Dickinson And Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Full blood count IVD, reagent.
- COULTER diff Ac•T Tainer Reagent Kit — Beckman Coulter, Inc. · Class I
- Swelab Lumi-L2 Lyse — Boule Medical AB · Class I
- COULTER Isoton III Diluent — Beckman Coulter, Inc. · Class I
- Medonic M51-D Diluent — Boule Medical AB · Class I
- COULTER diff Ac•T PAK Reagent Kit — Beckman Coulter, Inc. · Class I
- COULTER LH Series PAK Reagent Kit — Beckman Coulter, Inc. · Class I
- COULTER Lyse S III diff Lytic Reagent — Beckman Coulter, Inc. · Class I
- COULTER diff Ac•T PAK Reagent Kit — Beckman Coulter, Inc. · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Becton Dickinson And Company
Sources (1)
- FDA UDI bffa23c5-aa8d-48fa-a79d-80cbc18f9bbf 36 fields · synced May 31, 2026