Identity
- Trade Name
- RONDEX CPR ISO-VALVE (Made in USA) FDA UDI
- Generic Name
- Non-rebreathing valve, single-use FDA UDI
- Device Name
- The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.) FDA UDI
- Model / Reference
- 4040 (packaged in polybag) FDA UDI
- Description
- The RONDEX CPR ISO-VALVE Model #4040 is for emergency used only with a suitable CPR mask. It contains a total of two (2) silicone valves to help isolate the rescuer from the patient's breath. Fits masks with 15 mm OD stem or 22 mm ID opening. Made in USA (ISO-VALVE(TM) of Rondex Products, Inc.) FDA UDI
Identifiers
- Catalog Number
- 4040 FDA UDI
- Primary DI / UDI-DI
- 06343760040409 FDA UDI
- 510(k) Number
- K943761 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 ISO-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 ec344df9-9a31-462b-ac5e-4c3e9ab7e769 38 fields · synced Jun 8, 2026