Identity
- Trade Name
- Adsafe™ FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- ADSAFE Face Shield Plus,Adult,w/keychain,Roy Blue,Disp FDA UDI
- Model / Reference
- 4056RBQ FDA UDI
- Description
- ADSAFE Face Shield Plus,Adult,w/keychain,Roy Blue,Disp FDA UDI
Identifiers
- Catalog Number
- 4056RBQ FDA UDI
- Primary DI / UDI-DI
- 00634782058258 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
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
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HCT/P
No
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Premarket Exempt
Yes
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Lot / Batch Number
Yes
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Serial Number
No
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Expiration Date
No
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Manufacturing Date
No
FDA UDI
Category: Cardiopulmonary resuscitation mask, reusable
A flexible, reusable face shield designed for cardiopulmonary resuscitation (CPR) during emergency medical services (EMS).
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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
- American Diagnostic Corporation
Sources (1)
- FDA UDI 270e69c1-6784-428f-9b61-dc7d793d48f3 35 fields · synced Oct 6, 2026