NormaTec MVP 10500

GUDID 00817369020026

NormaTec MVP Control Unit

NORMATEC INDUSTRIES LP

Intermittent venous compression system
Primary Device ID00817369020026
NIH Device Record Keyaffb4e90-052d-4300-af7f-1a0cd0b71f90
Commercial Distribution StatusIn Commercial Distribution
Brand NameNormaTec MVP
Version Model NumberPPS-101
Catalog Number10500
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817369020026 [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 Date2016-09-14

Devices Manufactured by NORMATEC INDUSTRIES LP

00810050281713 - NormaTec2024-08-05 Normatec Hose Attachment
00810050281812 - NormaTec2024-08-05 Normatec right arm attachment
00810050286053 - NormaTec2024-05-31 Normatec Elite standard leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve min
00810050281997 - NormaTec2024-05-21 Normatec 3 is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor muscle aches and / o
00810050286077 - NormaTec2024-05-06 Normatec Elite short leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor
00810050286084 - NormaTec2024-05-06 Normatec Elite tall leg system is a powered air pressure inflatable tube massager. It is intended to temporarily relieve minor m
00810050281294 - NormaTec2023-06-26
00810050281720 - NormaTec2023-06-26

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