Identity
- Trade Name
- Silicone mask FDA UDI
- Generic Name
- Cardiopulmonary resuscitation mask, reusable FDA UDI
- Device Name
- Silicone mask provide a method to transfer breathing oxygen gas from a storage tank to lungs FDA UDI
- Model / Reference
- PN-0503-22A FDA UDI
- Description
- Silicone mask provide a method to transfer breathing oxygen gas from a storage tank to lungs FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719872103929 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
Category: Cardiopulmonary resuscitation mask, reusable
Silicone mask by Enter Medical Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- MICROTEK — Microtek Medical LLC · Class II
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- Pocket Mask w/O2, SP (Black IE) — Laerdal Medical Corp. · Class II
- HEADSTAR — Headstar Medical Products Co., Ltd. · 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
- Enter Medical Corporation
Sources (1)
- FDA UDI 4a43b496-e414-4b1e-a284-f176932fef92 33 fields · synced May 30, 2026