Curlin IV Pump System - Curlin IV Pump System - ZEVEX INTERNATIONAL, INC.

Duns Number:612746933

Device Description: Curlin IV Pump System

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More Product Details

Catalog Number

-

Brand Name

Curlin IV Pump System

Version/Model Number

Curlin Pump

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

FRN

Product Code Name

Pump, Infusion

Device Record Status

Public Device Record Key

2c9e097f-4b7c-4312-822c-e7f1e06a41a6

Public Version Date

May 07, 2021

Public Version Number

1

DI Record Publish Date

April 29, 2021

Additional Identifiers

Package DI Number

30814844000376

Quantity per Package

1

Contains DI Package

10814844000365

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"ZEVEX INTERNATIONAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 106