3-Ply Disposable Surgical Face Masks

GUDID 00850022550003

American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3

Armbrust Inc.

Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use Surgical/medical respirator, non-antimicrobial, single-use
Primary Device ID00850022550003
NIH Device Record Key46af33c9-26fa-4193-ada2-71f0683e7760
Commercial Distribution StatusIn Commercial Distribution
Brand Name3-Ply Disposable Surgical Face Masks
Version Model Number850022550003
Company DUNS117532009
Company NameArmbrust Inc.
Device Count50
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com
Phone512-807-0744
Emailsupport@armbrustusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022550003 [Primary]
GS100850022550010 [Unit of Use]

FDA Product Code

FXXMask, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2023-01-27

Devices Manufactured by Armbrust Inc.

00850022550003 - 3-Ply Disposable Surgical Face Masks2023-09-13American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3
00850022550003 - 3-Ply Disposable Surgical Face Masks2023-09-13 American Made Surgical Masks, 3-Ply Disposable Surgical Face Masks, ASTM Level 3
00850022550218 - Fold Flat Surgical Mask2023-09-13 Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating
00850022550249 - American Kid Disposable Face Maks2023-09-13 3-Ply Disposable Face Masks, ASTM F2100 Level 3
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