Pocket Mask, SP Blue
Ref 82002110Model Laerdal Pocket Mask
Active
CE MDR
Valid until
Not listed
FDA recalls
Not checked
Documents
None linked in EUDAMED
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing GUDID | Number07045432118223 | Date27 Aug 2025 | StatusListed |
| European Union | CE/MDR EUDAMED | Number0704543209939TB 07045432118223 | Date17 Nov 2022 | StatusActive |
Certificates
EUDAMED lists no certificate for this device's Basic UDI-DI.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Pocket Mask, SP Blue EUDAMEDPocket Mask, SP Blue (DE FR ES IT EN) GUDID
- Generic Name
- Cardiopulmonary resuscitation mask, reusable
- Model / Ref / Catalog
- Laerdal Pocket Mask EUDAMED82002110 EUDAMED82002133 GUDID
- Primary DI / UDI-DI
- 07045432118223
- Basic UDI-DI
- 0704543209939TB
- FDA Product Code
- KGB, CBP
- EMDN Code
- R03010201 Air/oxygen masks
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable
- Device Class
- Class I
- Regulation Number
- 868.5570, 868.5870
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / Reference | Laerdal Pocket Mask 82002110 | 82002133 |
Manufacturer details
- EUDAMED SRN
- NO-MF-000000012
Other devices from Laerdal Medical AS
Properties
Other properties (23)
- 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
- Prescription Use: 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