ICU Medical - Neonatal Pediatric Transpac™IT Monitoring Kit, - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Neonatal Pediatric Transpac™IT Monitoring Kit, 30ml Flush, Safeset™ Reservoir and Needlele Neonatal Pediatric Transpac™IT Monitoring Kit, 30ml Flush, Safeset™ Reservoir and Needleless Valve

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More Product Details

Catalog Number

42800-38

Brand Name

ICU Medical

Version/Model Number

42800-38

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"

Yes

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

39e30476-27c3-45cb-bbe8-101540fb27cc

Public Version Date

September 06, 2021

Public Version Number

1

DI Record Publish Date

August 29, 2021

Additional Identifiers

Package DI Number

10887709098104

Quantity per Package

20

Contains DI Package

00887709098107

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