Identity
- Trade Name
- JMU FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- ASTM Level 3 Four-Layer Medical Masks, Adult Size (17.5cmx9.5cm), Blue, 50pcs/box,40boxes/case FDA UDI
- Model / Reference
- 24007001 FDA UDI
- Description
- ASTM Level 3 Four-Layer Medical Masks, Adult Size (17.5cmx9.5cm), Blue, 50pcs/box,40boxes/case FDA UDI
Identifiers
- Primary DI / UDI-DI
- D930240070010 FDA UDI
- 510(k) Number
- K220597 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Public 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Public face mask, single-use
Jmu by Jmu Dental, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Public face mask, single-use.
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- ZhengKang — Guangzhou Zhengkang Medical Equipment Co., Ltd · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
- Halyard — O&M HALYARD, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
Cleared under the same submission
K220597 also covers:
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
- Jmu Dental, Inc
Sources (1)
- FDA UDI 3d6860d9-e9f7-44a9-8307-e16eabe71bd6 34 fields · synced May 31, 2026