Microfiber Pouch 30302

GUDID 00817369020682

Microfiber Pouch - Pulse

NORMATEC INDUSTRIES LP

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system
Primary Device ID00817369020682
NIH Device Record Key4ea79821-0d07-4766-b304-948656f6793f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMicrofiber Pouch
Version Model NumberMicrofiber Pouch - Pulse
Catalog Number30302
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
GS100817369020682 [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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