Identity
- Trade Name
- GEM Premier 5000 PAK BG ISE COOX TBILI (75 TEST) FDA UDI
- Generic Name
- Multiple blood gas/haemoximetry/electrolyte analyte IVD, kit, multiple technologies FDA UDI
- Device Name
- GEM 5000 BG ISE COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) FDA UDI
- Model / Reference
- 00055407509XC FDA UDI
- Description
- GEM 5000 BG ISE COOX TBILI 75 Test PAK 31 DAY (pH, pCO2, pO2, Na+, K+, Cl-, Ca++, Hct, tHb, O2Hb, COHb, HHb, MetHb, sO2, Tbili Cartridge) FDA UDI
Identifiers
- Catalog Number
- 00055407509XC FDA UDI
- Primary DI / UDI-DI
- 08426951027323 FDA UDI
- 510(k) Number
- K160412 FDA UDI
- FDA Product Code
- CHL 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 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 ISE COOX TBILI (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
K160412 also covers:
- 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 (450 TEST) — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG COOX (600 TEST) — INSTRUMENTATION LABORATORY COMPANY
- GEM Premier 5000 PAK BG COOX (75 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 COOX TBILI (75 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
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 75bf2080-0c47-483c-94d5-361db8bdd0eb 37 fields · synced Jun 8, 2026