Identity
- Trade Name
- JMU FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- ASTM Level 2 Medical Masks, Adult Size (17.5 cm x 9.5 cm), pink, 50 pcs/box, 40 boxes/case. FDA UDI
- Model / Reference
- 24004002 FDA UDI
- Description
- ASTM Level 2 Medical Masks, Adult Size (17.5 cm x 9.5 cm), pink, 50 pcs/box, 40 boxes/case. FDA UDI
Identifiers
- Primary DI / UDI-DI
- D930240040020 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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- 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 3742b645-7923-4cad-96a0-6c88354df10a 34 fields · synced Jun 1, 2026