Identity
- Trade Name
- O-Two FDA UDI
- Generic Name
- Anaesthesia face mask, single-use FDA UDI
- Device Name
- The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #3 cuff mask 02FM5203 fits small Adult patients. FDA UDI
- Model / Reference
- 02FM5207 FDA UDI
- Description
- The Single-use cuff mask comes with an air cushion pad to provide comfort for the patient. It is designed to be positioned over a patient’s nose or mouth to direct oxygen or anesthetic gases or aerosols to the upper airway. The size #3 cuff mask 02FM5203 fits small Adult patients. FDA UDI
Identifiers
- Catalog Number
- 02FM5207-CS FDA UDI
- Primary DI / UDI-DI
- 07540195010338 FDA UDI
- FDA Product Code
- BSJ FDA UDI
- GMDN Term
- Anaesthesia face mask, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5550 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia face mask, single-use
O-Two by O-Two Medical Technologies Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia face mask, single-use.
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- King Mask — Ambu A/S · Class I
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
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI 4e7d376b-ae5f-4997-9dbf-05a3eb97ca3c 36 fields · synced Jun 8, 2026