Identity
- Trade Name
- ICU Medical FDA UDI
- Generic Name
- Blood transfusion set, non-exchange FDA UDI
- Device Name
- 55" 210 Micron Blood Filter Set w/Rotating Luer FDA UDI
- Model / Reference
- B3232 FDA UDI
- Description
- 55" 210 Micron Blood Filter Set w/Rotating Luer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887709005471 FDA UDI
- 510(k) Number
- K983559 FDA UDI
- FDA Product Code
- FJK FDA UDI
- GMDN Term
- Blood transfusion set, non-exchange FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5820 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
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
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: Blood transfusion set, non-exchange
ICU Medical by Icu Medical, Inc. — 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
- CLEARLINK — BAXTER INTERNATIONAL INC. · Class II
- CODAN — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
- Walrus — CODAN US Corporation · Class II
Cleared under the same submission
K983559 also covers:
- AMSafe® 102" (259cm) Y-Type Blood Set — AMSINO INTERNATIONAL, INC.
- AMSafe® 105" (267cm) Y-Type Blood Set — AMSINO INTERNATIONAL, INC.
- AMSafe® 94" (239cm) Y-Type Blood Set — AMSINO INTERNATIONAL, INC.
- BD Blood Pump transfusion set — AMSINO INTERNATIONAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
- ICU Medical — ICU MEDICAL, INC.
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
- Icu Medical, Inc.
Sources (1)
- FDA UDI 41ecfd82-48c8-480d-b175-197172b1e473 34 fields · synced May 30, 2026