CUSTOMED 9002218

GUDID M20890022181

SURGICAL MASK, BLUE, WITH TIES, 80MM HG

CUSTOMED INC

Surgical/medical face mask, single-use
Primary Device IDM20890022181
NIH Device Record Key533b7db8-744c-43be-96d2-14eea80446ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOMED
Version Model Number712057462218
Catalog Number9002218
Company DUNS627572217
Company NameCUSTOMED 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 Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone787-622-5151
Emailcustomer.service@customedhealing.com

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM20890022180 [Unit of Use]
HIBCCM20890022181 [Primary]
HIBCCM20890022182 [Package]
Package: 50/BOX, 6BOX/CS [6 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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-05-06
Device Publish Date2016-09-23

On-Brand Devices [CUSTOMED]

M20890010702STERILIZATION WRAPPER DISPOSABLE 36" X 36"
M2089000862STERILIZATION WRAPPER DISPOSABLE 54" X 54"
M2089000852STERILIZATION WRAPPER DISPOSABLE 45" X 45"
M2089000842STERILIZATION WRAPPER DISPOSABLE 40" X 40"
M2089000832STERILIZATION WRAPPER DISPOSABLE 30" X 30"
M2089000822STERILIZATION WRAPPER DISPOSABLE 24" X 24"
M2089000812STERILIZATION WRAPPER DISPOSABLE 20" X 20"
M2089000792STERILIZATION WRAPPER DISPOSABLE 15" X 15"
M2089000782STERILIZATION WRAPPER DISPOSABLE 10" X 10"
M208CUS182SUCTION CATHETER 18FR
M208CUS160SUCTION CATHETER 16FR
M208CUS140SUCTION CATHETER 14FR
M208CUS120SUCTION CATHETER 12FR
M208CUS100SUCTION CATHETER 10FR
M208CUS080SUCTION CATHETER 8FR
M208CUS060SUCTION CATHETER 6FR
M2089002098072 HOUR 14FR TRACH CARE KIT WITH DOUBLE SWIVEL ELBOW, NORMAL SALINE SOLUTION
M20890022201SURGICAL MASK BLUE, VISOR, ANTI-FOG, AQUA WITH TIES, 160MM HG
M20890022191SURGICAL MASK, SOFT, WHITE, WITH TIES, 120MM HG
M20890022181SURGICAL MASK, BLUE, WITH TIES, 80MM HG
M20890022171SURGICAL MASK, BLUE, WITH TIES, 120 MM HG
M20890022161SURGICAL MASK, BLUE, WITH TIES, 80MM HG
M20890022151PROCEDURE MASK, VISOR, ANTI-FOG, AQUA WITH EAR LOOPS, 160MM HG
M20890022141PROCEDURE MASK, YELLOW, EAR LOOP, 80MM HG
M20890022131SURGICAL MASK, ANTI-FOG ADHESIVE TAPE, GREEN 80MM HG
M20890027812DISPOSABLE MUCUS TRAP, 80 ML (CC)
M20890027800DISPOSABLE MUCUS TRAP, 40 ML (CC)
M20890046952ICE BAG WITH CLOSE CLAMP WHITE, LARGE
M20890046942ICE BAG WITH CLOSE CLAMP WHITE, SMALL
M20890040520CUSTOMED DISPOSABLE UNDERPADS 30 X 70 IN
M2089004051C2CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES X-LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED
M2089004050C2CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED
M2089004049C2CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES MEDIUM POWDER FREE CHEMOTHERAPY DRUG TESTED
M2089004048C2CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES SMALL POWDER FREE CHEMOTHERAPY DRUG TESTED
M20890031440CUSTOMED UNDERPADS 23" X 36" , 15/BAG, 10BAG/CS
M20890030930CUSTOMED DISPOSABLE UNDERPADS 30 X 36 IN
M20890030920CUSTOMED DISPOSABLE UNDERPADS 23 X 36 IN
M20890029880CUSTOMED ADULT DISPOSABLE BRIEF XX-LARGE
M20890029870CUSTOMED ADULT DISPOSABLE BRIEF X-LARGE
M20890029860CUSTOMED ADULT DISPOSABLE BRIEF LARGE
M20890029850CUSTOMED ADULT DISPOSABLE BRIEF REGULAR
M20890029840CUSTOMED ADULT DISPOSABLE BRIEF MEDIUM
M20810063640OR TURNOVER DRAPE WITH TRANSFER SHEET
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