Identity
- Trade Name
- Phoenix Diagnostics FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, control FDA UDI
- Device Name
- LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L3 FDA UDI
- Model / Reference
- 1008AM FDA UDI
- Description
- LiquiTrol BGM - Blood Gas / Electrolyte / Metabolite Control - L3 FDA UDI
Identifiers
- Catalog Number
- 1008AM FDA UDI
- Primary DI / UDI-DI
- 10852676007138 FDA UDI
- 510(k) Number
- K920285 FDA UDI
- FDA Product Code
- JJS FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
- Total Volume — 2 Milliliter FDA UDI
Category: Multiple blood gas analyte IVD, control
Phoenix Diagnostics by Phoenix Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple blood gas analyte IVD, control.
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- Audit MicroControls Cal Ver LQ Blood Gas — Aalto Scientific, Ltd.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class I
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC. · Class I
Cleared under the same submission
K920285 also covers:
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, INC.
- Phoenix Diagnostics — PHOENIX DIAGNOSTICS, 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 I | Pending data |
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Manufacturer
- Manufacturer
- Phoenix Diagnostics, Inc.
Sources (1)
- FDA UDI 364131c9-3191-4544-9b0f-b0a669347a3d 38 fields · synced Jun 8, 2026