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Pocket Mask O2 HC White BoundTree (EN)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 830047Model Pocket Mask with Oxygen Inlet
Identity
- Trade Name
- Pocket Mask O2 HC White BoundTree (EN) EUDAMEDBoundTree CPR Mask w/O2, one-way valve and filter FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Pocket Mask with Oxygen Inlet EUDAMEDThe BoundTree CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
- Model / Reference
- Pocket Mask with Oxygen Inlet EUDAMED830047 EUDAMEDFDA UDI
- Description
- The BoundTree CPR Mask is primarily designed for mouth-to-mouth ventilation of a non-breathing adult. FDA UDI
Identifiers
- Catalog Number
- 830047 FDA UDI
- Primary DI / UDI-DI
- 07045430044647 EUDAMEDFDA UDI
- Basic UDI-DI
- 0704543209940SU EUDAMED
- Direct Marketing DI
- 07045430044647 EUDAMED
- FDA Product Code
- CBP FDA UDI
- EMDN Code
- R03010201 AIR/OXYGEN MASKS EUDAMED
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5870 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Pocket Mask O2 HC White BoundTree (EN) by Laerdal Medical AS — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0704543209940SU | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Laerdal Medical AS
- EUDAMED SRN
- NO-MF-000000012
Sources (2)
- EUDAMED dea39c31-4026-4574-b046-f656d47daa9a 61 fields · synced Jul 17, 2026
- FDA UDI 75c519b8-ed8b-48b8-82fb-4f41f0104b94 36 fields · synced May 30, 2026