Identity
- Trade Name
- Sechrist Air/Oxygen Gas Mixer EUDAMEDSechrist Industries, Inc. FDA UDI
- Generic Name
- Oxygen/air breathing gas mixer, hospital FDA UDI
- Device Name
- Sechrist Air/Oxygen gas Mixer EUDAMEDMIXER,3500,POLE MNT FDA UDI
- Model / Reference
- 20459 EUDAMEDFDA UDI
- Description
- MIXER,3500,POLE MNT FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00899660002611 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00899660002611 EUDAMED
- 510(k) Number
- K992503 FDA UDI
- FDA Product Code
- BZR FDA UDI
- EMDN Code
- V0903 CLINICAL/THERAPEUTIC APPLICATIONS GAS MIXTURES EUDAMED
- GMDN Term
- Oxygen/air breathing gas mixer, hospital FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5330 FDA UDI
- Market of Registration
- Czechia EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Depth — 5 Inch FDA UDIWidth — 4 Inch FDA UDIWeight — 3 Pound FDA UDIHeight — 6 Inch FDA UDI
Sechrist Air/Oxygen Gas Mixer by Sechrist Industries Inc — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00899660002611 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Sechrist Industries Inc
- EUDAMED SRN
- US-MF-000017869
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (2)
- EUDAMED 6478cbf6-ee76-4cbf-b9fe-54f3caa30c72 61 fields · synced Jul 29, 2026
- FDA UDI e996d355-e9e1-4a48-a06e-9a176b4dae98 36 fields · synced May 30, 2026