Identity
- Trade Name
- LEADER FDA UDI
- Generic Name
- Public respirator, single-use FDA UDI
- Device Name
- LDR N95 Masks 5 ea FDA UDI
- Model / Reference
- 5512934 FDA UDI
- Description
- LDR N95 Masks 5 ea FDA UDI
Identifiers
- Catalog Number
- 5512934 FDA UDI
- Primary DI / UDI-DI
- 00096295137385 FDA UDI
- 510(k) Number
- K061375 FDA UDI
- FDA Product Code
- MSH FDA UDI
- GMDN Term
- Public respirator, 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
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Public respirator, single-use
Leader by Cardinal Health 110, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Public respirator, single-use.
- WeCare — Jeg & Sons Inc. · Class II
- WeCare — Jeg & Sons Inc. · N
- Pasture A520G Respirator — Pasture Pharma Pte, Ltd. · Class II
- INSTAGARD — Cardinal Health 200, LLC · Class II
- Care One — Apothecary Products, Inc. · Class II
- Pasture F550G Respirator — Pasture Pharma Pte, Ltd. · Class II
- VINMASK — NHAT QUANG INDUSTRY COOPERATIVE · Class II
- FLENTS — Apothecary Products, Inc. · 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.
- GERSON — LOUIS M. GERSON CO., INC.
- Marketlab Inc — MARKETLAB 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
- Cardinal Health 110, Inc.
Sources (1)
- FDA UDI 77b11594-2d1e-4279-bf05-430b028ca527 36 fields · synced May 30, 2026