Identity
- Trade Name
- Criterion OxiCheck FDA UDI
- Generic Name
- Respiratory oxygen monitor, battery-powered FDA UDI
- Model / Reference
- 00 FDA UDI
Identifiers
- Catalog Number
- 8-100661-00 FDA UDI
- Primary DI / UDI-DI
- 00884838083189 FDA UDI
- FDA Product Code
- CCL FDA UDI
- GMDN Term
- Respiratory oxygen monitor, battery-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1720 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
No
FDA UDI
Category: Respiratory oxygen monitor, battery-powered
Criterion OxiCheck by Respironics Novametrix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Respiratory oxygen monitor, battery-powered.
- MiniOX — Ohio Medical LLC · Class II
- MAX02 ME — Maxtec, Inc. · Class II
- Precision Medical Inc. — PRECISION MEDICAL, INC. · Class II
- Analytical Industries Inc. — ANALYTICAL INDUSTRIES, INC. · Class II
- Bio-Med Devices, Inc. — Bio-Med Devices, Inc. · Class II
- MAXVENTURI — Maxtec, Inc. · Class II
- MAXVENTURI — Maxtec, Inc. · Class II
- Analytical Industries Inc. — ANALYTICAL INDUSTRIES, INC. · Class II
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
- Respironics Novametrix, LLC
Sources (1)
- FDA UDI 1baeb5e5-007d-4937-b1de-793f09da3c78 35 fields · synced Jun 8, 2026