Identity
- Trade Name
- NEIL MEDICAL FDA UDI
- Generic Name
- Surgical/medical face mask, non-antimicrobial, reusable FDA UDI
- Device Name
- Disposable Face Mask Level 1 FDA UDI
- Model / Reference
- FM1010 FDA UDI
- Description
- Disposable Face Mask Level 1 FDA UDI
Identifiers
- Catalog Number
- FM1010 FDA UDI
- Primary DI / UDI-DI
- 00850063139267 FDA UDI
- 510(k) Number
- K202708 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical face mask, non-antimicrobial, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical face mask, non-antimicrobial, reusable
Neil Medical by Neil Medical Group — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K202708 also covers:
- Procedure Face Masks with Ear Loop, Blue, Glass-Free Filter — Dynarex Corp.
- EXCEL Procedure Mask 3 ply level 1, 50 per box, mint green — Excel Gloves & Safety Supplies, Inc.
- Procedure Mask 3 ply level 1, color 50 per box, BLACK — Excel Gloves & Safety Supplies, Inc.
- BASIC — Intco Medical Industries, Inc.
- BASIC — Intco Medical Industries, Inc.
- PurCel Labs ASTM Level 1 Surgical Masks — Purcel Labs LLC
- PurCel Labs Individually Wrapped ASTM Level 1 Surgical Masks — Purcel Labs LLC
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 II | Pending data |
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Manufacturer
- Manufacturer
- Neil Medical Group
Sources (1)
- FDA UDI 90c7418f-de0e-4e02-9f36-c2966f1c2b2e 35 fields · synced May 30, 2026