Identity
- Trade Name
- O-Two Disposable Pressure manometer 0-20cmH2O FDA UDI
- Generic Name
- Airway pressure monitor, non-powered FDA UDI
- Device Name
- O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure is desired. This device provides a visual indication of air way pressure to be used on O_Two Single-use "open Circuit" CPAP System. FDA UDI
- Model / Reference
- 01CV8066 FDA UDI
- Description
- O-Two Disposable Pressure Manometer is intended for use where monitoring airway pressure is desired. This device provides a visual indication of air way pressure to be used on O_Two Single-use "open Circuit" CPAP System. FDA UDI
Identifiers
- Catalog Number
- 01CV8066 FDA UDI
- Primary DI / UDI-DI
- 07540195037007 FDA UDI
- 510(k) Number
- K102377 FDA UDI
- FDA Product Code
- CAP FDA UDI
- GMDN Term
- Airway pressure monitor, non-powered FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.2600 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Airway pressure monitor, non-powered
O-Two Disposable Pressure manometer 0-20cmH2O by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K102377 also covers:
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
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI a77e4baa-2d2b-4729-96a3-b188822f41ed 37 fields · synced Jun 6, 2026