CareOne - Butterfly Closures, all one size, 1 3/4 IN x 3/8 - Ahold U.S.A., Inc.

Duns Number:170199058

Device Description: Butterfly Closures, all one size, 1 3/4 IN x 3/8 IN

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More Product Details

Catalog Number

-

Brand Name

CareOne

Version/Model Number

041520863461

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)

-

Over the Counter (OTC)

Yes

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

985e31e7-707e-45d4-b400-f260fe3ad6b0

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Additional Identifiers

Package DI Number

10041520963465

Quantity per Package

72

Contains DI Package

00041520863461

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"AHOLD U.S.A., INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 28
2 A medical device with a moderate to high risk that requires special controls. 12
U Unclassified 2