Identity
- Trade Name
- MediPure Blood Gas Mixture FDA UDI
- Generic Name
- Multiple blood gas analyte IVD, calibrator FDA UDI
- Device Name
- Blood Gas Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- Blood Gas Mixture (of Specified Concentration) GAS, CALIBRATION (SPECIFIED CONCENTRATION) - Blood Gas Mixture FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850046301179 FDA UDI
- FDA Product Code
- BXK FDA UDI
- GMDN Term
- Multiple blood gas analyte IVD, calibrator FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6400 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multiple blood gas analyte IVD, calibratorBlood gas analyser IVD, point-of-care
MediPure Blood Gas Mixture by Linde Gas & Equipment Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Linde Gas & Equipment Inc.
Sources (1)
- FDA UDI d55a7ecc-362f-48c9-951e-6d201b6ca8fc 33 fields · synced Sep 18, 2026