Diana Peristaltic Pump Module - Diana Peristaltic Pump - ICU MEDICAL, INC.

Duns Number:118380146

Device Description: Diana Peristaltic Pump

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More Product Details

Catalog Number

DS1000

Brand Name

Diana Peristaltic Pump Module

Version/Model Number

DS1000

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

-

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

-

Product Code Details

Product Code

NEP

Product Code Name

System/device, pharmacy compounding

Device Record Status

Public Device Record Key

1450b7ab-6eef-432f-892b-254fc38a0ba2

Public Version Date

May 04, 2021

Public Version Number

1

DI Record Publish Date

April 26, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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