IV3000 10X20CM CTN 50 - Moisture responsive IV catheter dressing - SMITH & NEPHEW MEDICAL LIMITED

Duns Number:216344051

Device Description: Moisture responsive IV catheter dressing

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More Product Details

Catalog Number

4649

Brand Name

IV3000 10X20CM CTN 50

Version/Model Number

4649

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)

-

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

0cfceae9-427f-4541-b5c8-925c35b1b3dc

Public Version Date

July 08, 2020

Public Version Number

2

DI Record Publish Date

May 15, 2020

Additional Identifiers

Package DI Number

05000223410810

Quantity per Package

50

Contains DI Package

05000223426668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

carton

"SMITH & NEPHEW MEDICAL LIMITED" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 63
2 A medical device with a moderate to high risk that requires special controls. 126
U Unclassified 1