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SleepWeaver Elan - Mask Only - Small - Camo
FDA UDIClass II (US FDA UDI)
by Circadiance
Identity
- Trade Name
- SleepWeaver Elan - Mask Only - Small - Camo FDA UDI
- Generic Name
- CPAP/BPAP nasal mask, reusable FDA UDI
- Device Name
- SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Camo FDA UDI
- Model / Reference
- 100745 FDA UDI
- Description
- SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Camo FDA UDI
Identifiers
- Catalog Number
- 100745 FDA UDI
- Primary DI / UDI-DI
- B036100745 FDA UDI
- 510(k) Number
- K120757 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
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: CPAP/BPAP nasal mask, reusable
SleepWeaver Elan - Mask Only - Small - Camo by Circadiance — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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
K120757 also covers:
- SleepWeaver Elan - Mask & Headgear - Large - Beige — Circadiance
- SleepWeaver Elan - Mask & Headgear - Large - Blue — Circadiance
- SleepWeaver Elan - Mask & Headgear - Large - Camo — Circadiance
- SleepWeaver Elan - Mask & Headgear - Large - Leopard — Circadiance
- SleepWeaver Elan - Mask & Headgear - Large - Pink — Circadiance
- SleepWeaver Elan - Mask & Headgear - Regular - Beige — Circadiance
- SleepWeaver Elan - Mask & Headgear - Regular - Blue — Circadiance
- SleepWeaver Elan - Mask & Headgear - Regular - Camo — Circadiance
- SleepWeaver Elan - Mask & Headgear - Regular - Leopard — Circadiance
- SleepWeaver Elan - Mask & Headgear - Regular - Pink — Circadiance
- SleepWeaver Elan - Mask & Headgear - Small - Beige — Circadiance
- SleepWeaver Elan - Mask & Headgear - Small - Blue — Circadiance
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
- Circadiance
Sources (1)
- FDA UDI f603768c-9ae0-43e8-a58a-75f0a216e4bb 36 fields · synced Jun 9, 2026