CUSTOMED 9004050C

GUDID M2089004050C2

CUSTOMGUARD DISPOSABLE NITRILE EXAM GLOVES LARGE POWDER FREE CHEMOTHERAPY DRUG TESTED

CUSTOMED INC

Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial Nitrile examination/treatment glove, non-powdered, non-antimicrobial
Primary Device IDM2089004050C2
NIH Device Record Keyd3d5cb36-a193-41f8-b46f-24c307e3eb1f
Commercial Distribution StatusIn Commercial Distribution
Brand NameCUSTOMED
Version Model Number712057700050
Catalog Number9004050C
Company DUNS627572217
Company NameCUSTOMED INC
Device Count200
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 Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com
Phone787.622.5151
Emailcustomerservice@prhospital.com

Device Dimensions

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Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry ventilated environment. Do not store above 100F (37C). Avoid direct sunlight, flourescent lighting, heat and moisture.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM2089004050C0 [Unit of Use]
HIBCCM2089004050C1 [Primary]
HIBCCM2089004050C2 [Package]
Contains: M2089004050C1
Package: 200/BX, 10BX/CS [2000 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LZAPolymer Patient Examination Glove

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-18
Device Publish Date2023-08-10

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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