NormaTec Pulse 10100

GUDID 00817369020002

NormaTec Pulse Control Unit

NORMATEC INDUSTRIES LP

Sequential venous compression system Sequential venous compression system Sequential venous compression system
Primary Device ID00817369020002
NIH Device Record Keyde7117ef-554b-4242-8d7d-5bd572bfa8f4
Commercial Distribution StatusIn Commercial Distribution
Brand NameNormaTec Pulse
Version Model NumberJMS4
Catalog Number10100
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 19 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 106 KiloPascal
Storage Environment Atmospheric PressureBetween 19 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS100817369020002 [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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