Zhende

GUDID 00850006820061

Zhende Disposable face mask,Blue,Narrow Spandex Ear Loops, pack of 50pcs, 2 packs, 100pcs

Boston Bgecare Inc

Surgical/medical face mask, non-antimicrobial, single-use
Primary Device ID00850006820061
NIH Device Record Key9e3d00fa-727f-4450-880d-de462a0bb56d
Commercial Distribution StatusIn Commercial Distribution
Brand NameZhende
Company DUNS056757726
Company NameBoston Bgecare Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850006820061 [Primary]

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 Date2023-11-27
Device Publish Date2023-11-18

On-Brand Devices [Zhende]

00850006820252Zhende AAMI3 Surgical Gown with Reinforcement, 45g/m2 SMS, Level 3, AAMI3,FDA registered, 28 pa
00850006820061Zhende Disposable face mask,Blue,Narrow Spandex Ear Loops, pack of 50pcs, 2 packs, 100pcs

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