FLOWTRON UNIVERSAL

GUDID 05055982700146

DVT Prevention Compression Pump - FLOWTRON UNIVERSAL USA OR

Arjohuntleigh AB

Intermittent venous compression system
Primary Device ID05055982700146
NIH Device Record Key22f4bf43-8cca-4ae0-9b8f-d93a7e895a8f
Commercial Distribution StatusIn Commercial Distribution
Brand NameFLOWTRON UNIVERSAL
Version Model Number507003OR
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
GS105055982700146 [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 Date2016-08-26

On-Brand Devices [FLOWTRON UNIVERSAL]

05055982700146DVT Prevention Compression Pump - FLOWTRON UNIVERSAL USA OR
05055982700139DVT Prevention Compression Pump - FLOWTRON UNIVERSAL USA

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