Amerisource Bergen

GUDID 80368001105473

Face Mask with earloops & Visor Blue, Anti-Fog, Anti-Glare Level3

BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY

Surgical/medical face mask, single-use
Primary Device ID80368001105473
NIH Device Record Key103f630a-6830-442f-93e4-0301548186b2
Commercial Distribution StatusIn Commercial Distribution
Brand NameAmerisource Bergen
Version Model Number10547
Company DUNS985523874
Company NameBP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Device Count25
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100368001105477 [Primary]
GS120368001105471 [Package]
Contains: 00368001105477
Package: [4 Units]
In Commercial Distribution
GS180368001105473 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

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 Date2021-03-08
Device Publish Date2021-02-26

On-Brand Devices [Amerisource Bergen]

80368001105473Face Mask with earloops & Visor Blue, Anti-Fog, Anti-Glare Level3
00368001113052Non-adherent Pads Sterile 2in X 3in
00368001113021Non adherent Pads sterile 3in x 8in
00368001113014Non-adherent Pads Sterile 3in x 4in
60368001100528NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: LARGE
60368001100511NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: MEDIUM
80368001100508NITRILE EXAM GLOVES POWDER FREE LILAC COLOUR SIZE: SMALL
60368001114051Disposable Underpads Premium 23inX36in ( 58.4gm X 91.4cm)

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