Left Arm Sleeve Black 20204

GUDID 00817369020408

Left Arm Sleeve Black

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00817369020408
NIH Device Record Key20b8da84-6eb7-4063-8734-59d676fe6686
Commercial Distribution StatusIn Commercial Distribution
Brand NameLeft Arm Sleeve Black
Version Model NumberLeft Arm Sleeve Black
Catalog Number20204
Company DUNS111448069
Company NameNORMATEC INDUSTRIES LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100817369020408 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IRPMassager, Powered Inflatable Tube

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-13

Devices Manufactured by NORMATEC INDUSTRIES LP

00810050281294 - NormaTec2023-06-26
00810050281720 - NormaTec2023-06-26
00810050281768 - NormaTec 2023-06-26
00810050281782 - NormaTec2023-06-26
00810050281805 - NormaTec2023-06-26
00810050281829 - NormaTec2023-06-26
00810050281836 - NormaTec2023-06-26
00810050281881 - NormaTec2023-06-26

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