Identity
- Trade Name
- 805X - CPRotector® - 1/Unit FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- 805X - CPRotector® - 1/Unit FDA UDI
- Model / Reference
- R216-068 FDA UDI
- Description
- 805X - CPRotector® - 1/Unit FDA UDI
Identifiers
- Catalog Number
- R216-068 FDA UDI
- Primary DI / UDI-DI
- 00766588160689 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
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Non-rebreathing valve, single-use
805X - CPRotector® - 1/Unit by Certified Safety Manufacturing, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- 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 - Black Mini Pouch — 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
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
- Certified Safety Manufacturing, Inc.
Sources (1)
- FDA UDI 75d02741-c2c5-474e-986e-db537164e12f 36 fields · synced May 30, 2026