FLOWTRON EXCEL

GUDID 05055982700016

DVT Prevention Compression Pump - FLOWTRON EXCEL AC550 PUMP

Arjohuntleigh AB

Intermittent venous compression system
Primary Device ID05055982700016
NIH Device Record Key0ad709e8-9be1-4d4f-9a42-bde9bb796178
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOWTRON EXCEL
Version Model Number247001
Company DUNS355804758
Company NameArjohuntleigh AB
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
GS105055982700016 [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 Number4
Public Version Date2019-04-29
Device Publish Date2016-09-23

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