Identity
- Trade Name
- HEADSTAR FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #4 Silicone mask with PC dome for Small Adult Headstar offers anatomically designed face mask that brings maximum comfort to the patient. FDA UDI
- Model / Reference
- HS-8804P FDA UDI
- Description
- Headstar 100% latex-free face masks come in a wide variety of sizes and materials to suit the patient's needs. #4 Silicone mask with PC dome for Small Adult Headstar offers anatomically designed face mask that brings maximum comfort to the patient. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04711402231331 FDA UDI
- FDA Product Code
- BYG FDA UDI
- GMDN Term
- Cardiopulmonary resuscitation mask, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.5580 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Cardiopulmonary resuscitation mask, reusable
Headstar by Headstar Medical Products Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MICROTEK — Microtek Medical LLC · Class II
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
- Headstar Medical Products Co., Ltd.
Sources (1)
- FDA UDI dd152b2c-036d-4e54-8947-ac7a2c2eb7fb 33 fields · synced May 30, 2026