Flowtron - DVT Prevention Compression Garment - DVT 30 - Arjohuntleigh AB

Duns Number:355804758

Device Description: DVT Prevention Compression Garment - DVT 30 STERILE - CALF/THIGH

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More Product Details

Catalog Number

-

Brand Name

Flowtron

Version/Model Number

DVT30S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 09, 2020

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JOW

Product Code Name

SLEEVE, LIMB, COMPRESSIBLE

Device Record Status

Public Device Record Key

07eb1577-7f76-4c3d-b46b-5d332a7e9dcf

Public Version Date

September 05, 2022

Public Version Number

6

DI Record Publish Date

September 23, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ARJOHUNTLEIGH AB" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 420
2 A medical device with a moderate to high risk that requires special controls. 840