Halyard - AVID MEDICAL, INC.

Duns Number:015623119

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More Product Details

Catalog Number

AMCL05N

Brand Name

Halyard

Version/Model Number

AMCL05N_0001

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

Yes

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

OES

Product Code Name

Cardiac catheterization kit

Device Record Status

Public Device Record Key

4edfc246-1b93-46d6-8ea0-067fc85ddfac

Public Version Date

September 19, 2022

Public Version Number

1

DI Record Publish Date

September 09, 2022

Additional Identifiers

Package DI Number

20809160384111

Quantity per Package

4

Contains DI Package

10809160384114

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"AVID MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 5180
2 A medical device with a moderate to high risk that requires special controls. 28744