Identity
- Trade Name
- I-MED Single Use Face Mask FDA UDI
- Generic Name
- Face splash shield, single-use FDA UDI
- Device Name
- Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer FDA UDI
- Model / Reference
- 5300 FDA UDI
- Description
- Single-use face shield is intended to be worn by personnel during medical procedures to protect both the patient and the operating personnel from transfer of microorganisms, body fluids and particulate material transfer FDA UDI
Identifiers
- Catalog Number
- 5300 FDA UDI
- Primary DI / UDI-DI
- 00622554053006 FDA UDI
- FDA Product Code
- HOY FDA UDIQLA FDA UDIQLB FDA UDI
- GMDN Term
- Face splash shield, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4750 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
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: Face splash shield, single-use
I-MED Single Use Face Mask by I-Med Pharma Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- I-Med Pharma Inc
Sources (1)
- FDA UDI de2ba942-101d-48d3-9669-94162f103b4b 35 fields · synced Jun 6, 2026