Identity
- Trade Name
- OxyMask™ FDA UDI
- Generic Name
- Breathing circuit gas-sampling/monitoring set FDA UDI
- Device Name
- OxyChin Mask ETCO2, 7ft oxygen tubing, 8in sampling line with female connector FDA UDI
- Model / Reference
- OC-2025-8 FDA UDI
- Description
- OxyChin Mask ETCO2, 7ft oxygen tubing, 8in sampling line with female connector FDA UDI
Identifiers
- Catalog Number
- OC-2025-8 FDA UDI
- Primary DI / UDI-DI
- 10620974000133 FDA UDI
- FDA Product Code
- CCK FDA UDI
- GMDN Term
- Breathing circuit gas-sampling/monitoring set FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.1400 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
OxyMask™ by Southmedic Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
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Manufacturer
- Manufacturer
- Southmedic Incorporated
Sources (1)
- FDA UDI 855e6da2-937d-4aea-9a7c-439587711e1e 37 fields · synced Jun 1, 2026