Transpac™ - Cath Lab Kit w/Waste Bag, dyePod®, Sosa Spike & - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Cath Lab Kit w/Waste Bag, dyePod®, Sosa Spike & Syringe

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More Product Details

Catalog Number

460980411

Brand Name

Transpac™

Version/Model Number

460980411

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

K941254,K941254

Product Code Details

Product Code

DQO

Product Code Name

CATHETER, INTRAVASCULAR, DIAGNOSTIC

Device Record Status

Public Device Record Key

0f33cf7f-6f64-4d77-9a07-d6eeee40e59f

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Additional Identifiers

Package DI Number

10840619063259

Quantity per Package

5

Contains DI Package

00840619063252

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS

"ICU MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4887