Identity
- Trade Name
- CPR Bio-Barrier Training Faceshield FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission. FDA UDI
- Model / Reference
- 01RB5050U FDA UDI
- Description
- CPR Bio-Barrier Training Faceshield is intended to provide CPR trained individuals with personal protection from disease transmission during Expired Air Resuscitation (mouth to mouth) and during CPR training on manikins. The use if this device does not guarantee complete protection from disease transmission. FDA UDI
Identifiers
- Catalog Number
- 01RB5050 FDA UDI
- Primary DI / UDI-DI
- 07540195056008 FDA UDI
- 510(k) Number
- K960995 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Face splash shield, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 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: Face splash shield, single-use
CPR Bio-Barrier Training Faceshield by O-Two Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 398457ff-783e-4138-8e82-d571028eff78 35 fields · synced May 30, 2026