ArjoHuntleigh DVT Sleeve - Huntleigh DVT Flowtron Calf 17in. Garment - RENU MEDICAL, INC

Duns Number:100439103

Device Description: Huntleigh DVT Flowtron Calf 17in. Garment

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More Product Details

Catalog Number

-

Brand Name

ArjoHuntleigh DVT Sleeve

Version/Model Number

RM-DVT10

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

K031559,K031559

Product Code Details

Product Code

JOW

Product Code Name

Sleeve, Limb, Compressible

Device Record Status

Public Device Record Key

493a12f1-56f1-4171-9ae5-6f96078ed237

Public Version Date

August 02, 2019

Public Version Number

4

DI Record Publish Date

August 23, 2016

Additional Identifiers

Package DI Number

10816317020177

Quantity per Package

10

Contains DI Package

00816317020170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"RENU MEDICAL, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 68
2 A medical device with a moderate to high risk that requires special controls. 95