Identity
- Trade Name
- Sapphire FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (previously Hospira product) FDA UDI
- Model / Reference
- 1638401 FDA UDI
- Description
- SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch (previously Hospira product) FDA UDI
Identifiers
- Catalog Number
- 1638401 FDA UDI
- Primary DI / UDI-DI
- 10887787007449 FDA UDI
- 510(k) Number
- K171346 FDA UDI
- FDA Product Code
- MRZ FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5725 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 123 Inch FDA UDI
Category: Electric infusion pump administration set, single-use
Sapphire by Icu Medical Fleet Services, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Electric infusion pump administration set, single-use.
- MODD1 Infusion Set, 10 Pack — Modular Medical, Inc. · Class II
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- Clear-View Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- Alaris, SmartSite — BD Switzerland Sàrl · Class II
- Clear-View Multi-site Subcutaneous Infusion Set — NORFOLK MEDICAL · Class II
- CADD — ICU MEDICAL, INC. · Class II
- Infusomat® — B. BRAUN MEDICAL INC. · Class II
- Alaris — BD Switzerland Sàrl · Class II
Cleared under the same submission
K171346 also covers:
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
- Sapphire — ICU MEDICAL FLEET SERVICES, LLC
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 Fleet Services, Llc
Sources (1)
- FDA UDI cc83cfbb-a68b-4678-98de-27f8a9c3ab61 38 fields · synced May 29, 2026