Transpac - Transpac™ IT Monitoring Kit w/Safeset™ 84" - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeez Transpac™ IT Monitoring Kit w/Safeset™ 84" Arterial Pressure Tubing, Reservoir, 3ml Squeeze Flush and 2 Needleless Valves

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

47100-02

Brand Name

Transpac

Version/Model Number

47100-02

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

K052828,K052828

Product Code Details

Product Code

DRS

Product Code Name

Transducer, blood-pressure, extravascular

Device Record Status

Public Device Record Key

1cd15d1b-7541-479f-a8c6-792a111c4898

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 20, 2021

Additional Identifiers

Package DI Number

10887709123967

Quantity per Package

20

Contains DI Package

00887709123960

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"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