Identity
- Trade Name
- EXTENSION SET FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- Blood Extension Set FDA UDI
- Model / Reference
- 2N3383 FDA UDI
- Description
- Blood Extension Set FDA UDI
Identifiers
- Catalog Number
- 2N3383 FDA UDI
- Primary DI / UDI-DI
- 00085412653303 FDA UDI
- 510(k) Number
- K210335 FDA UDI
- FDA Product Code
- BRZ FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5440 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Total Volume — 4.7 Milliliter FDA UDILength — 150 Centimeter FDA UDI
Category: Blood transfusion set, non-exchange
Extension Set by Baxter Healthcare Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood transfusion set, non-exchange.
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- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · 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
- Baxter Healthcare Corp
Sources (1)
- FDA UDI be50cb8e-411d-4503-bd69-02ca3186f567 38 fields · synced May 30, 2026