BGEcare Disposable Face Mask

GUDID 06959385795930

BGEcare Disposable Face Mask, Blue, Narrow Spandex Ear Loops, 50 pieces/box, 40 boxes/carton box

Zhende Medical Co., Ltd.

Surgical/medical face mask, single-use
Primary Device ID06959385795930
NIH Device Record Key52e150e5-cecd-4c15-8b8d-3ed4d445d23a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBGEcare Disposable Face Mask
Version Model NumberMM17185040L1
Company DUNS654591569
Company NameZhende Medical Co., Ltd.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106959385795930 [Primary]
GS106959385795947 [Package]
Package: carton box [40 Units]
In Commercial Distribution

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-03-12
Device Publish Date2021-03-04

On-Brand Devices [BGEcare Disposable Face Mask]

06959385795930BGEcare Disposable Face Mask, Blue, Narrow Spandex Ear Loops, 50 pieces/box, 40 boxes/carton box
06959385795923BGEcare Disposable Face Mask, Blue, Narrow Spandex Ear Loops, 30 pieces/box, 60 pboxes/carton bo

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