Identity
- Trade Name
- Nasal CPAP Mask — Medium FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- Includes 1 medium sized mask, with headgear and replaceable cushion. FDA UDI
- Model / Reference
- CM006MPL FDA UDI
- Description
- Includes 1 medium sized mask, with headgear and replaceable cushion. FDA UDI
Identifiers
- Catalog Number
- CM006MPL FDA UDI
- Primary DI / UDI-DI
- 00848530088866 FDA UDI
- 510(k) Number
- K063268 FDA UDI
- FDA Product Code
- BZD FDA UDI
- GMDN Term
- CPAP/BPAP nasal mask, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5905 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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, reusable
Nasal CPAP Mask — Medium by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as CPAP/BPAP nasal mask, reusable.
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- Dream Wisp — Respironics, Inc. · Class II
- ROSCOE — COMPASS HEALTH BRANDS CORP. · Class I
- DreamWear Gel Pillow — Respironics, Inc. · Class II
Cleared under the same submission
K063268 also covers:
- Classic Full Face CPAP Mask with Headgear - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Full Face CPAP Mask with Headgear - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Full Face CPAP Mask with Headgear - Small — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Nasal CPAP Mask with Headgear - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Classic Nasal CPAP Mask with Headgear - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear* — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Large *No Headgear* - Retail — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium *No Headgear* — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Medium *No Headgear* -Retail — SUNSET HEALTHCARE SOLUTIONS, Inc.
- Deluxe Full Face CPAP Mask with Removable Cushion - Small — SUNSET HEALTHCARE SOLUTIONS, Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI 844e94d0-f39e-4548-b5f9-637a7598f7af 36 fields · synced May 31, 2026