Pulse Pro Upper Body Recovery Package 40210

GUDID 00817369021191

Pulse Pro Recovery Package - Upper Body

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00817369021191
NIH Device Record Key3ea511ce-e961-4507-b9c5-5a9cfc20fbe9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePulse Pro Upper Body Recovery Package
Version Model NumberPulse Pro Recovery Package - Upper Body
Catalog Number40210
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 Numbertrue
Manufacturing Datetrue
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
GS100817369021191 [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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