Identity
- Trade Name
- I-MED Surgical Mask FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Mask 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
- 5100 FDA UDI
- Description
- Mask 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
- 5100 FDA UDI
- Primary DI / UDI-DI
- 00622554051002 FDA UDI
- FDA Product Code
- QKR FDA UDI
- GMDN Term
- Surgical/medical face mask, single-use FDA UDI
Classification
- Device Class
- N 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: Surgical/medical face mask, single-use
I-MED Surgical Mask by I-Med Pharma Inc — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, single-use.
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- Precept® — Precept Medical Products, Inc. · Class II
- AOSHANG — Tianjin Aoshang Outdoor Equipment Co., Ltd. · Class II
- Precept® — Precept Medical Products, Inc. · Class II
- Precept® — Precept Medical Products, Inc. · Class II
- Surgical Face Mask — Foshan Nanhai Plus Medical Co., Ltd · 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 N | Pending data |
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Manufacturer
- Manufacturer
- I-Med Pharma Inc
Sources (1)
- FDA UDI 4cce8307-6f1f-422f-96b9-f5ed62702816 35 fields · synced Jun 7, 2026