Identity
- Trade Name
- Pocket Mask SP w/o wipe (Blue CDN) FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant. FDA UDI
- Model / Reference
- 82004020 FDA UDI
- Description
- The Pocket Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult, child or infant. FDA UDI
Identifiers
- Catalog Number
- 82004020 FDA UDI
- Primary DI / UDI-DI
- 07045430079670 FDA UDI
- FDA Product Code
- CBP FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, reusable
Pocket Mask SP w/o wipe (Blue CDN) by Laerdal Medical Corp. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical Corp.
Sources (2)
- FDA UDI 5e45e9ce-6be1-46ab-82b2-3791acb09b3b 36 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026