← Back to catalogue
Rondex CPR Pocket Rescue Mask (Made in USA) #91402 with O2 inlet. inlet
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Rondex CPR Pocket Rescue Mask (Made in USA) #91402 with O2 inlet. inlet FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- The Rondex CPR Pocket Rescue Mask, Model #91402 with an oxygen inlet stem, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA FDA UDI
- Model / Reference
- 91402 (packaged in clamshell case) FDA UDI
- Description
- The Rondex CPR Pocket Rescue Mask, Model #91402 with an oxygen inlet stem, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There are two (2) silicone valves inside the valve housing to help isolate the patient's breath from the rescuer. The mask has a unique design (Design Registered) that even allows rescuers with small hands or rescuers with wet hands a more comfortable means to hold the mask. The mask can be folded down and stored in the plastic clamshell case along with the valve. Made In USA FDA UDI
Identifiers
- Catalog Number
- 91402 FDA UDI
- Primary DI / UDI-DI
- 06343760914021 FDA UDI
- 510(k) Number
- K943761 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, 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
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
Rondex CPR Pocket Rescue Mask (Made in USA) #91402 with O2 inlet. inlet by Rondex Products, Incorporated — Class II — FDA UDI — listed in FDA GUDID
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Rondex Products, Incorporated
Sources (1)
- FDA UDI 8395db69-5556-4ffc-a81a-b01e3c2bb8ae 38 fields · synced May 30, 2026