Pulse Boot Set 40020

GUDID 00817369020781

Pulse Standard Boot Set

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00817369020781
NIH Device Record Key96fbffdb-22f1-47a3-a03b-022bcb4dfae8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Boot Set
Version Model NumberPulse Standard Boot Set
Catalog Number40020
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
GS100817369020781 [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 Set]

00817369020835Pulse Tall Power Boot Set
00817369020828Pulse Standard Power Boot Set
00817369020811Pulse Short Power Boot Set
00817369020804Pulse Short Boot Set
00817369020798Pulse Tall Boot Set
00817369020781Pulse Standard Boot Set

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