Identity
- Trade Name
- Universal Headgear FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- Universal Headgear. One size fits most, can be used with most 4-point nasal or full face CPAP masks. FDA UDI
- Model / Reference
- HG003 FDA UDI
- Description
- Universal Headgear. One size fits most, can be used with most 4-point nasal or full face CPAP masks. FDA UDI
Identifiers
- Catalog Number
- HG003 FDA UDI
- Primary DI / UDI-DI
- 00848530080228 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Anaesthesia mask strap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Anaesthesia mask strap, reusable
Universal Headgear by SUNSET HEALTHCARE SOLUTIONS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Anaesthesia mask strap, reusable.
- Headgear disp., soft rub., large — Drägerwerk AG & Co. KGaA · Class I
- Carex Health Brands — COMPASS HEALTH BRANDS CORP. · Class I
- Underarm Straps — Intersurgical Incorporated · Class I
- BreatheWear Halo Chinstrap by Marpac — Marpac, Inc. · Class I
- Headgaer disp., soft fabric, la. — Drägerwerk AG & Co. KGaA · Class I
- Inspire — Inspiration Healthcare, Ltd. · Class I
- Adult Large Head Strap For CPAP Mask — FLEXICARE MEDICAL LIMITED · Class I
- Headgear disp., soft rub., small — Drägerwerk AG & Co. KGaA · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- SUNSET HEALTHCARE SOLUTIONS, Inc.
Sources (1)
- FDA UDI fde513e8-1e87-49e0-8270-c7241cb5c7cc 35 fields · synced May 30, 2026