The CPR Mask with Oxygen Inlet
by Laerdal Medical AS EUDAMEDGUDID
Active
Ref 830045Model Pocket Mask with Oxygen Inlet
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0704543209940SU | Date17 Nov 2022 | StatusActive |
| United States | GUDID listing GUDID | Number07045430044623 | Date20 Oct 2015 | StatusIn distribution |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
- European Union
- United States
Specification
- Trade Name
- The CPR Mask with Oxygen Inlet EUDAMEDDynamed CPR Mask w/O2, Green GUDID
- Generic Name
- Cardiopulmonary resuscitation mask, reusable
- Device Name
- Pocket Mask with Oxygen Inlet
- Model / Ref / Catalog
- Pocket Mask with Oxygen Inlet, 830045
- Primary DI / UDI-DI
- 07045430044623
- Basic UDI-DI
- 0704543209940SU
- Direct Marketing DI
- 07045430044623
- FDA Product Code
- CBP
- EMDN Code
- R03010199 Ventilation masks - other
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable
- Device Class
- Class IIa EUDAMEDClass II GUDID
- Regulation Number
- 868.5870
- Market of Registration
- Norway
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Device Class | Class IIa | Class II |
Manufacturer details
- EUDAMED SRN
- NO-MF-000000012
Other devices from Laerdal Medical AS
Properties
Other properties (22)
- Sterile: No
- Single Use: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
- Expiration Date: No
- Manufacturing Date: No