Plum - LATEX-FREE PRIMARY PLUMSET, Yellow Striped - HOSPIRA, INC.

Duns Number:141588017

Device Description: LATEX-FREE PRIMARY PLUMSET, Yellow Striped Tubing, Convertible Pin, 107 Inch with OPTION-L LATEX-FREE PRIMARY PLUMSET, Yellow Striped Tubing, Convertible Pin, 107 Inch with OPTION-LOK

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More Product Details

Catalog Number

0644013

Brand Name

Plum

Version/Model Number

644013

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

-

Product Code Details

Product Code

FRN

Product Code Name

Pump, infusion

Device Record Status

Public Device Record Key

fff7c165-fad7-466c-be7d-dabc90a83581

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

20887787006661

Quantity per Package

48

Contains DI Package

10887787006664

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"HOSPIRA, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 7