NormaTec MVP Pro 10602

GUDID 00817369020057

NormaTec MVP Pro w/NT conn., not lighted

NORMATEC INDUSTRIES LP

Intermittent venous compression system Intermittent venous compression system Intermittent venous compression system
Primary Device ID00817369020057
NIH Device Record Keyecf67b5b-d0ed-4915-9778-8a633090b159
Commercial Distribution StatusIn Commercial Distribution
Brand NameNormaTec MVP Pro
Version Model NumberAL-5C1A
Catalog Number10602
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100817369020057 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOWSleeve, Limb, Compressible

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

On-Brand Devices [NormaTec MVP Pro]

00817369020071NormaTec MVP Pro w/CPC conn., lighted
00817369020064NormaTec MVP Pro w/NT conn., lighted, 220v
00817369020057NormaTec MVP Pro w/NT conn., not lighted
00817369020040NormaTec MVP Pro w/CPC conn., not lighted
00817369020033NormaTec MVP Pro

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