Identity
- Trade Name
- Marketlab Inc FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- N95 Resp w/Exhal Valve,Individ Pkgd,Flat Fold PK20 (1 box) FDA UDI
- Model / Reference
- 21597 FDA UDI
- Description
- N95 Resp w/Exhal Valve,Individ Pkgd,Flat Fold PK20 (1 box) FDA UDI
Identifiers
- Catalog Number
- 21597 FDA UDI
- Primary DI / UDI-DI
- 00817517020199 FDA UDI
- 510(k) Number
- K061375 FDA UDI
- FDA Product Code
- MSH FDA UDI
- GMDN Term
- Surgical/medical face mask, single-use 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
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
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical/medical face mask, single-use
Marketlab Inc by Marketlab Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical face mask, single-use.
- ProGear — Prestige Ameritech · Class II
- Precept® — Precept Medical Products, Inc. · Class II
- hcs — DYAD MEDICAL SOURCING, LLC · Class I
- 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
Cleared under the same submission
K061375 also covers:
- All Pro — Bunzl USA Holdings LLC
- SAS Safety / Gerson — Bunzl USA Holdings LLC
- Crosstex™ Isolator™ Duckbill N95 Surgical Respirator — CROSSTEX INTERNATIONAL, INC.
- Crosstex™ Isolator™ Molded N95 Surgical Respirator — CROSSTEX INTERNATIONAL, INC.
- LEADER — Cardinal Health 110, Inc.
- GERSON — LOUIS M. GERSON CO., INC.
- Marketlab Inc — MARKETLAB INC.
- PureLife N95 — PURELIFE, 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
- Marketlab Inc.
Sources (1)
- FDA UDI 3e6dd1c7-ea42-47d6-86d7-b0e181718270 36 fields · synced May 30, 2026