DEVICE: Premium Plus (D125FS2288B2)
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If so, send a picture of the label to
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Device Identifier (DI) Information
Premium Plus
FS2288B
In Commercial Distribution
FS2288
Premium Plus (Dongguan) Limited
FS2288B
In Commercial Distribution
FS2288
Premium Plus (Dongguan) Limited
Disposable Medical Face Masks (Ear Loop with Shield)
Device Characteristics
| Labeling does not contain MRI Safety Information | |
| No | |
| Yes | |
| Yes | |
| Yes | |
| 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? |
|---|---|---|---|---|
| 66199 | Surgical/medical face mask, non-antimicrobial, single-use |
A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and 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) and/or transparent face/eye visor. This is a single-use device.
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| LYU | Accessory, Surgical Apparel |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| Premarket Submission Number Not Available/Not Released | |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| No Device Sizes |
Device Record Status
57a02d60-7a1a-463f-80ad-a0bfd6fb07d9
May 28, 2026
1
May 20, 2026
May 28, 2026
1
May 20, 2026
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| D125FS2288B8 | 20 | D125FS2288B2 | In Commercial Distribution | Case |
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
D125FS2288B0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined