← Back to catalogue
FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S +2 more)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 1137918Model DreamWisp Nasal Mask with Over the Nose Cushion
Identity
- Trade Name
- FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S, M, L Cushions) EUDAMEDDreamWisp FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- FitPack, DreamWisp Nasal Mask with Medium Connector without Headgear, Global FDA UDI
- Model / Reference
- DreamWisp Nasal Mask with Over the Nose Cushion EUDAMED1137918 EUDAMEDFitPack DreamWisp Mask, Med Connector, w/o Headgear, Global FDA UDI
- Description
- FitPack, DreamWisp Nasal Mask with Medium Connector without Headgear, Global FDA UDI
Identifiers
- Catalog Number
- 1137918 FDA UDI
- Primary DI / UDI-DI
- 00606959050983 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00606959050983 EUDAMED
- FDA Product Code
- BZD FDA UDI
- EMDN Code
- R0301010202 NIV MASKS EUDAMED
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
- Models / Variants
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Market of Registration
- Austria 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
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: Rebreathing oxygen face mask
FitPack, DreamWisp Nsl, Med Con w/o Hgr GBL (S +2 more) by Respironics, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — 3 models
Similar devices
Also classified as Rebreathing oxygen face mask.
- DUAL MASK-ADULT MALE NOSE CLIP MC WITH CO2 MONIT 7FT (USA) — FLEXICARE MEDICAL LIMITED · Class II
- Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class I
- Ventlab — Ventlab Corp. · Class I
- Mask — Beijing Rongrui-Century Science & Technology Co. , Ltd. · Class IIa
- AMARA MASK WITH RS FRAME AND HEADGEAR LARGE, INTL — Respironics Inc. · Class IIa
- ClasStar, GanzGesMask, NIV, AAV, L — Drägerwerk AG & Co. KGaA · Class IIa
- Venticaire Lite — FLEXICARE MEDICAL LIMITED · Class I
- Oro-Nasal Mask — HANS RUDOLPH, INC. · Class IIa
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00606959050983 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Respironics Inc.
- EUDAMED SRN
- US-MF-000002301
- Authorised Representative
- Respironics Deutschland GmbH & Co.KG DE-AR-000006164
Sources (3)
- EUDAMED 667fd08d-a8ec-45bd-8273-bb72a74464f8 61 fields · synced Jun 18, 2026
- FDA UDI 5a9a47b5-bd71-474b-ab02-7a320375fed1 36 fields · synced May 29, 2026
- EUDAMED e6b1a6be-320c-40ab-886f-9fe307680dbf 61 fields · synced Jun 18, 2026