Fold Flat Surgical Mask

GUDID 00850022550218

Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating

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 ID00850022550218
NIH Device Record Key431c8ce0-6cec-4842-adbc-81096787e76b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFold Flat Surgical Mask
Version Model Number850022550218
Company DUNS117532009
Company NameArmbrust Inc.
Device Count20
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@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com
Phone512-807-0744
Emailsupport@armbrust.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in cool, dry place. Avoid excessive heat about 140 degrees F.

Device Identifiers

Device Issuing AgencyDevice ID
GS100850022550218 [Primary]
GS100850022550256 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-13
Device Publish Date2023-01-27

Devices Manufactured by Armbrust Inc.

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00850022550218 - Fold Flat Surgical Mask2023-09-13Flat Fold Surgical Mask, Behind the ears loops, ASTM F2100 Level 3 Rating
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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