AIME 1776

GUDID 10850025200025

Disposable 3-ply earloop procedure mask

AIME USA LLC

Surgical/medical face mask, single-use
Primary Device ID10850025200025
NIH Device Record Keye1601951-f9ae-4902-bc7a-417d45f4575a
Commercial Distribution StatusIn Commercial Distribution
Brand NameAIME 1776
Version Model NumberGFM12
Company DUNS117707985
Company NameAIME USA LLC
Device Count50
DM Exempttrue
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

Customer Support Contacts

Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com
Phone430-264-3872
Emailsupport@aimeusa.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850025200028 [Unit of Use]
GS110850025200025 [Primary]

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 Date2020-12-01
Device Publish Date2020-11-23

On-Brand Devices [AIME 1776]

10850025200025Disposable 3-ply earloop procedure mask
00850025200011Disposable 3-ply earloop procedure mask

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