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Rondex CPR Pocket Rescue Mask (Made in USA) model #9120
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Rondex CPR Pocket Rescue Mask (Made in USA) model #9120 FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, single-use FDA UDI
- Device Name
- The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone valve 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
- 9120 (packaged in a plastic clamshell case) FDA UDI
- Description
- The Rondex CPR Pocket Rescue Mask, Model #9120, is for emergency mouth-to-mask ventilation on a non-breathing adult or child. There is a silicone valve 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
- 9120 FDA UDI
- Primary DI / UDI-DI
- 06343760091203 FDA UDI
- 510(k) Number
- K902299 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
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 Pocket Rescue Mask (Made in USA) model #9120 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 |
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Manufacturer
- Manufacturer
- Rondex Products, Incorporated
Sources (1)
- FDA UDI dcf99a88-70bf-453d-9f6e-b1cd47b7119d 38 fields · synced May 30, 2026