Identity
- Trade Name
- ICU Medical, Inc. FDA UDI
- Generic Name
- Fluid transfer set, general-purpose FDA UDI
- Device Name
- GTIN for B33984, 1/EA FDA UDI
- Model / Reference
- B33984 FDA UDI
- Description
- GTIN for B33984, 1/EA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00887709127357 FDA UDI
- 510(k) Number
- K964435 FDA UDI
- FDA Product Code
- FMG FDA UDI
- GMDN Term
- Fluid transfer set, general-purpose 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Fluid transfer set, general-purpose
ICU Medical, Inc. by Icu Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fluid transfer set, general-purpose.
- PMI — PROGRESSIVE MEDICAL, INC. · Class II
- UNBRANDED — Advance Medical Designs, Inc. · Class II
- VOLMED BRASIL — VOLMED BRASIL EQUIPAMENTOS LTDA · Class I
- Set, I.V. Fluid Transfer — MPS MEDICAL, INC · Class II
- Single Lead High Volume Pump Chamber Set — MPS MEDICAL, INC · Class II
- Set, I.V. Fluid Transfer — MPS MEDICAL, INC · Class II
- Quick Fill Disposable Syringe Fill Tube — Bayer Medical Care Inc. · Class II
- VYGON — Vygon Corp. · Class II
Cleared under the same submission
K964435 also covers:
- 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.
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Icu Medical, Inc.
Sources (1)
- FDA UDI 1b9a9b85-13ce-4754-9ce8-c9564c02a2ef 34 fields · synced Jun 6, 2026