DEVICE: JMU (D930240070060)
Device Identifier (DI) Information
JMU
24007006
In Commercial Distribution
JMU DENTAL, INC
24007006
In Commercial Distribution
JMU DENTAL, INC
ASTM Level 3 Four-Layer Medical Masks, Adult Size (17.5cmx9.5cm), Pink, 50pcs/box,40boxes/case
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
64821 | Public face mask, single-use |
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire). This is a single-use device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FXX | Mask, Surgical |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K220597 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
96c8c66e-fcdb-4783-b62d-23ecc5c6e273
October 29, 2024
1
October 21, 2024
October 29, 2024
1
October 21, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined