CPRotector® - w/Gloves & Towelette - Black Mini Pouch
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- CPRotector® - w/Gloves & Towelette - Black Mini Pouch FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- CPRotector® - w/Gloves & Towelette - Black Mini Pouch FDA UDI
- Model / Reference
- R270-038 FDA UDI
- Description
- CPRotector® - w/Gloves & Towelette - Black Mini Pouch FDA UDI
Identifiers
- Catalog Number
- R270-038 FDA UDI
- Primary DI / UDI-DI
- 00766588700380 FDA UDI
- 510(k) Number
- K960587 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Non-rebreathing valve, 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
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
No
Category: Non-rebreathing valve, single-use
CPRotector - w/Gloves & Towelette - Black Mini Pouch is a single-use, non-rebreathing valve designed for use in breathing circuits or between an oxygen mask and its reservoir bag to prevent patient rebreathing of exhaled gases. It features a unique one-way design with a silicone or mica sheet/discs opening and closing with each inspiration/expiration.
Similar devices
Also classified as Non-rebreathing valve, single-use.
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Cleared under the same submission
K960587 also covers:
- 6PW - CPRotector® ONE Deluxe - Poly White — Certified Safety Manufacturing, Inc.
- 6PW - CPRotector® TWO Economy - Poly White — Certified Safety Manufacturing, Inc.
- 805X - CPRotector® - 1/Unit — Certified Safety Manufacturing, Inc.
- 810X - CPRotector® - w/Nitrile Gloves - 2/Unit — Certified Safety Manufacturing, Inc.
- 812X - CPRotector® - w/Nitrile Gloves & Towelette - 3/Unit — Certified Safety Manufacturing, Inc.
- CPRotector® - Black Micro Pouch — Certified Safety Manufacturing, Inc.
- CPRotector® - Orange Micro Pouch — Certified Safety Manufacturing, Inc.
- CPRotector® - Overwrap — Certified Safety Manufacturing, Inc.
- CPRotector® - w/Gloves & Towelette - Orange Mini Pouch — Certified Safety Manufacturing, Inc.
- CPRotector® - w/Gloves & Towelette - Overwrap — Certified Safety Manufacturing, Inc.
- CPRotector® - w/Nitrile Gloves - Black Mini Pouch — Certified Safety Manufacturing, Inc.
- CPRotector® - w/Nitrile Gloves - Orange Mini Pouch — Certified Safety Manufacturing, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 43f0f536-dd44-4723-ad94-c451ecb1831b 36 fields · synced Jul 24, 2026