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BreatheWear Halo Chinstrap by Marpac
FDA UDIClass I (US FDA UDI)
by Marpac, Inc.
Identity
- Trade Name
- BreatheWear Halo Chinstrap by Marpac FDA UDI
- Generic Name
- Anaesthesia mask strap, reusable FDA UDI
- Device Name
- BreatheWear brand halo chinstrap, manufactured by Marpac. Used by sleep apnea patients to keep the mouth closed during sleep. FDA UDI
- Model / Reference
- 8-H3407 FDA UDI
- Description
- BreatheWear brand halo chinstrap, manufactured by Marpac. Used by sleep apnea patients to keep the mouth closed during sleep. FDA UDI
Identifiers
- Catalog Number
- 8-H3407 FDA UDI
- Primary DI / UDI-DI
- 00858388004017 FDA UDI
- FDA Product Code
- BTK FDA UDI
- GMDN Term
- Anaesthesia mask strap, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5560 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
BreatheWear Halo Chinstrap by Marpac by Marpac, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Anaesthesia mask strap, reusable.
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- Universal Headgear — SUNSET HEALTHCARE SOLUTIONS, Inc. · Class I
- Headgaer disp., soft fabric, la. — 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
- Marpac, Inc.
Sources (1)
- FDA UDI 9b28f8c4-0041-4e16-ba29-dd4ff299e9d5 35 fields · synced May 30, 2026