Transpac - Transpac™ IT Monitoring Kit, 66" (168 cm) - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Transpac™ IT Monitoring Kit, 66" (168 cm) Pressure Tubing, 2 way stopcocks, 3ml Flush Devi Transpac™ IT Monitoring Kit, 66" (168 cm) Pressure Tubing, 2 way stopcocks, 3ml Flush Device and Admin Set

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More Product Details

Catalog Number

47000-06

Brand Name

Transpac

Version/Model Number

47000-06

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

a9814c22-3ba0-49a3-b3cf-2addb748c4e0

Public Version Date

November 29, 2021

Public Version Number

1

DI Record Publish Date

November 20, 2021

Additional Identifiers

Package DI Number

10887709124582

Quantity per Package

20

Contains DI Package

00887709124585

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