Identity
- Trade Name
- Rondex CPR Valve (Made in USA) FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA FDA UDI
- Model / Reference
- 2020 package in polybag FDA UDI
- Description
- The RONDEX CPR VALVE Model #2020 is for emergency used only with a suitable CPR mask to help isolate the patient's breath from the rescuer. . It has a single flapper valve which stays flexible under very cold conditions. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA FDA UDI
Identifiers
- Catalog Number
- 2020 FDA UDI
- Primary DI / UDI-DI
- 06343760020203 FDA UDI
- 510(k) Number
- K902299 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
- Not 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
Yes
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
Rondex CPR Valve (Made in USA) by Rondex Products, Incorporated — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Rondex Products, Incorporated
Sources (1)
- FDA UDI 67c608e9-ce87-406a-bc5b-e15d5747bdbd 38 fields · synced May 31, 2026