Impella - KIT, 14Fr INTRODUCER, 13&25 cm, ABMD - Abiomed, Inc.

Duns Number:050636737

Device Description: KIT, 14Fr INTRODUCER, 13&25 cm, ABMD

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More Product Details

Catalog Number

0052356

Brand Name

Impella

Version/Model Number

KIT, 14Fr INTRODUCER, 13&25 cm, ABMD

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

-

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

-

FDA Premarket Submission

K192769

Product Code Details

Product Code

DYB

Product Code Name

Introducer, Catheter

Device Record Status

Public Device Record Key

588409e1-c670-406e-8104-a3d6ee7ec83a

Public Version Date

April 23, 2020

Public Version Number

1

DI Record Publish Date

April 15, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ABIOMED, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16
3 A medical device with high risk that requires premarket approval 47