Isolation Gown - Blue

GUDID 00850015055089

ULINE, INC.

Isolation gown, single-use
Primary Device ID00850015055089
NIH Device Record Keyc9aa87ee-e6ac-475f-93f4-9bdfc917b7e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameIsolation Gown - Blue
Version Model NumberS-24019BLU
Company DUNS039612668
Company NameULINE, INC.
Device Count50
DM Exemptfalse
Pre-market Exempttrue
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-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850015055089 [Unit of Use]
GS110850015055086 [Primary]

FDA Product Code

OEANon-Surgical Isolation Gown

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-16
Device Publish Date2020-12-08

Devices Manufactured by ULINE, INC.

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30850015055530 - ULINE BULLET EARPLUGS - CORDED2024-07-31
30850015055547 - ULINE BELL EARPLUGS - UNCORDED2024-07-31
30850015055554 - ULINE BELL EARPLUGS - CORDED2024-07-31
30850015055493 - ULINE BULLET EARPLUGS REFILL2024-05-21
00850015055713 - ULINE EARPLUGS IN A BUCKET2024-05-21

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