ASTM Level 2 Surgical Face Mask

GUDID 00850019294002

3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex.

Premier Guard Usa, LLC

Surgical/medical face mask, single-use
Primary Device ID00850019294002
NIH Device Record Keya6185ede-142c-419f-9fda-f5034a17f729
Commercial Distribution StatusIn Commercial Distribution
Brand NameASTM Level 2 Surgical Face Mask
Version Model Number20-1003-SFM2
Company DUNS117537165
Company NamePremier Guard Usa, LLC
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com
Phone888-706-1231
EmailGlenn.Ferreri@premierguardusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850019294002 [Primary]
GS100850019294347 [Unit of Use]
GS120850019294006 [Package]
Package: Case [40 Units]
In Commercial Distribution

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 Date2021-12-02
Device Publish Date2021-11-24

Devices Manufactured by Premier Guard Usa, LLC

00850019294019 - ASTM Level 3 Surgical Face Mask2022-06-27 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural
00850019294026 - Face Mask2022-06-27 Case of 3-Ply, single use, disposable face mask. Made with elastic ear loops that do not contain natural rubber latex.
10850019294016 - ASTM Level 3 Surgical Face Mask case2022-05-02 Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 3 rating. Made with elastic ear loops that do not
20850019294006 - ASTM Level 2 Surgical Face Mask Case2022-05-02 Case of 3-Ply, single use, disposable surgical face masks with an ASTM Level 2 rating. Made with elastic ear loops that do not
00850019294002 - ASTM Level 2 Surgical Face Mask2021-12-023-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex.
00850019294002 - ASTM Level 2 Surgical Face Mask2021-12-02 3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural
00850019294156 - ASTM LEVEL 3 Surgical Face Mask2021-05-18 3-ply, single-use disposable surgical mask with a ASTM Level 3 rating. Made with elastic ear loops that do not contain natural

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