Pulse Boot 20000

GUDID 00817369020101

Pulse Standard Zippered Boot Black

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00817369020101
NIH Device Record Keya047483e-c7bb-4440-8bec-d7d6208bbb94
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Boot
Version Model NumberPulse Standard Zippered Boot Black
Catalog Number20000
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
GS100817369020101 [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

On-Brand Devices [Pulse Boot]

00817369020156Pulse Power Tall Zippered Boot Black
00817369020149Pulse Power Standard Zippered Boot Black
00817369020132Pulse Power Short Zippered Boot Black
00817369020125Pulse Short Zippered Boot Black
00817369020118Pulse Tall Zippered Boot Black
00817369020101Pulse Standard Zippered Boot Black

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