Identity
- Trade Name
- PN841 Mask, INTL, Child Large, Leak 3, ASM EUDAMEDPN841 FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, single-use FDA UDI
- Device Name
- PN841 Mask, INTL, Child Large, Leak 3, ASM EUDAMEDPN841 Mask, Child Large, Leak 3, International FDA UDI
- Model / Reference
- 1130575 EUDAMEDPN841 Mask, INTL, Child Large, Leak 3, ASM FDA UDI
- Description
- PN841 Mask, Child Large, Leak 3, International FDA UDI
Identifiers
- Catalog Number
- 1130575 FDA UDI
- Primary DI / UDI-DI
- 00606959041745 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959041745 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010201 CPAP MASKS EUDAMED
- GMDN Term
- CPAP/BPAP nasal mask, single-use FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Germany 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
Category: CPAP/BPAP nasal mask, single-use
Pn841 by Respironics, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as CPAP/BPAP nasal mask, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Respironics, Inc.
Sources (2)
- FDA UDI d945eee5-4f6e-4771-8723-345184fdeee0 36 fields · synced Aug 1, 2026
- EUDAMED 7f09f59d-6f74-4e9f-9ce6-183315ebfbf4 61 fields · synced Aug 1, 2026