Identity
- Trade Name
- Lifeshield FDA UDI
- Generic Name
- Electric infusion pump administration set, single-use FDA UDI
- Device Name
- Primary PLUM Set CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 104 Inch (previously Hospira product) FDA UDI
- Model / Reference
- 1495188 FDA UDI
- Description
- Primary PLUM Set CLAVE Secondary Port, Backcheck Valve, 2 CLAVE Y-Sites, Secure Lock, 104 Inch (previously Hospira product) FDA UDI
Identifiers
- Catalog Number
- 1495188 FDA UDI
- Primary DI / UDI-DI
- 10887787003205 FDA UDI
- 510(k) Number
- K141789 FDA UDI
- FDA Product Code
- FPA FDA UDI
- GMDN Term
- Electric infusion pump administration set, single-use 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 104 Inch FDA UDI
Category: Electric infusion pump administration set, single-use
Lifeshield 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.
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- Alaris, SmartSite — BD Switzerland Sàrl · Class II
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- CADD — ICU MEDICAL, INC. · Class II
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Cleared under the same submission
K141789 also covers:
- Lifeshield — ICU MEDICAL FLEET SERVICES, LLC
- Lifeshield — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- Plum — ICU MEDICAL FLEET SERVICES, LLC
- 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 Fleet Services, Llc
Sources (1)
- FDA UDI aceaad20-b36f-4bf7-9e6f-de2177391e0c 38 fields · synced May 30, 2026