Identity
- Trade Name
- Rescue Breather FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. FDA UDI
- Model / Reference
- 01RB1000U FDA UDI
- Description
- The Rescue Breather consists of a one-way valve that has a large block is placed in a patient's mouth, The person providing CPR then blows through the valve to inflate patient's lung. The intended purpose of the valve and the filter is to prevent any cross contamination and potential cross infection by preventing contact with body fluids such as vomit, blood or saliva between patient and first aid provider. FDA UDI
Identifiers
- Catalog Number
- 01RB1000 FDA UDI
- Primary DI / UDI-DI
- 07540195055018 FDA UDI
- 510(k) Number
- K940927 FDA UDI
- FDA Product Code
- LYM FDA UDI
- GMDN Term
- Face splash shield, single-use FDA UDI
Classification
- 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
Rescue Breather by O-Two Medical Technologies Inc — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Face splash shield, single-use.
- customized — Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Class I
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- No Brand — Smith & Nephew, Inc. · Class I
- Clear Choice — Southmedic Incorporated · Class I
- Splash Shield — BERKLEY MEDICAL RESOURCES, INC. · Class II
- Crosstex™ — HU-FRIEDY MFG CO., LLC · Class I
Cleared under the same submission
K940927 also covers:
- Rescue Breather CPR Protective Barrier — O-Two Medical Technologies Inc
- Rescue Breather CPR Protective Barrier — O-Two Medical Technologies Inc
- Rescue Breather CPR Protective Barrier — O-Two Medical Technologies Inc
- Rescue Breather CPR Protective Barrier — O-Two Medical Technologies Inc
- Rescue Breather CPR Protective Barrier — O-Two Medical Technologies Inc
- Rescue Breather CPR Protective barrier — O-Two Medical Technologies Inc
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- O-Two Medical Technologies Inc
Sources (1)
- FDA UDI 9d3dc24c-ddaa-474b-8f01-8db7f1f095cb 36 fields · synced May 30, 2026