CARDINAL HEALTH - NEEDLE/HOLDER CONVENIENCE KIT - Aero-Med, Ltd.

Duns Number:194550042

Device Description: NEEDLE/HOLDER CONVENIENCE KIT

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More Product Details

Catalog Number

AMM1675

Brand Name

CARDINAL HEALTH

Version/Model Number

AMM1675

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

LRP

Product Code Name

TRAY, SURGICAL

Device Record Status

Public Device Record Key

fe5deff6-4086-4044-8736-c65b3c4c5059

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

August 16, 2019

Additional Identifiers

Package DI Number

50810010892206

Quantity per Package

250

Contains DI Package

00810010892201

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"AERO-MED, LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 467
2 A medical device with a moderate to high risk that requires special controls. 14