CoFlex TLC - Two-Layer Compression KitLayer 1 is a soft foam - Andover Healthcare, Inc.

Duns Number:088528245

Device Description: Two-Layer Compression KitLayer 1 is a soft foam roll with odor and itch control properties Two-Layer Compression KitLayer 1 is a soft foam roll with odor and itch control properties and an excellent moisture transfer rate that wicks away any drainage to help keep the skin dry. Layer 2 is a non-latex short stretch compression bandage that sticks to itself with EasyTear technology, which eliminates the need for scissors. CoFlex® TLC provides a two-step level of comfort. LITE LY2 1" X 3.8 Yds

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More Product Details

Catalog Number

7802TN-21

Brand Name

CoFlex TLC

Version/Model Number

LITE LY2 1" X 3.8 Yds

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"

Yes

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

MHW

Product Code Name

Dressing, Compression

Device Record Status

Public Device Record Key

323f2be3-7784-489b-988c-91da975ed59f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

April 05, 2022

Additional Identifiers

Package DI Number

00724004621497

Quantity per Package

36

Contains DI Package

10724004621494

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ANDOVER HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55