Identity
- Trade Name
- GEM Premier 5000 PAK BG/COOX 75 TEST FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days FDA UDI
- Model / Reference
- 00055407504 FDA UDI
- Description
- GEM Premier 5000 PAK pH, pCO2, pO2, Hct, tHb, O2Hb, COHb, MetHb, HHb, sO2 75 Test 31 Days FDA UDI
Identifiers
- Catalog Number
- 00055407504 FDA UDI
- Primary DI / UDI-DI
- 08426950807537 FDA UDI
- FDA Product Code
- CHL FDA UDIGKF FDA UDI
- GMDN Term
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.1120 FDA UDI864.5600 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies
GEM Premier 5000 PAK BG/COOX 75 TEST by Instrumentation Laboratory Company — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies.
- ABL80 SC80 — Radiometer Medical ApS · Class II
- ABL80 SC80 — Radiometer Medical ApS · Class II
- ABL90 FLEX SP90 — Radiometer Medical ApS · Class II
- ABL90 Sensor Cassette pack — Radiometer Medical ApS · Class II
- ABL80 SC80 — Radiometer Medical ApS · Class II
- ABL80 SC80 — Radiometer Medical ApS · Class II
- ABL90 Sensor Cassette pack — Radiometer Medical ApS · Class II
- ABL80 SC80 — Radiometer Medical ApS · Class II
Cleared under the same submission
K160415 also covers:
- GEM Premier 5000 PAK BG/ COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANY
K173403 also covers:
- GEM Premier 5000 PAK BG/ COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANY
K203790 also covers:
- GEM Premier 5000 PAK BG/ COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/COOX/TBILI 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 150 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 300 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 450 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 600 TEST — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG/ISE/COOX 75 TEST — INSTRUMENTATION LABORATORY COMPANY
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
- Instrumentation Laboratory Company
Sources (1)
- FDA UDI f356a150-39c1-4c78-9118-8cf17b7bda1a 37 fields · synced Jun 1, 2026