Lifeshield - LIFESHIELD LATEX-FREE HEMA Y-TYPE TRANSFUSION - HOSPIRA, INC.

Duns Number:141588017

Device Description: LIFESHIELD LATEX-FREE HEMA Y-TYPE TRANSFUSION BLOOD SET, Nonvented, 100 Inch with Pump, 2 LIFESHIELD LATEX-FREE HEMA Y-TYPE TRANSFUSION BLOOD SET, Nonvented, 100 Inch with Pump, 2 CLAVE Ports and Secure Lock

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More Product Details

Catalog Number

1933048

Brand Name

Lifeshield

Version/Model Number

1933048

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

FPA

Product Code Name

Set, administration, intravascular

Device Record Status

Public Device Record Key

949d7f4b-3273-43fc-9d3d-2ebe59ff59f5

Public Version Date

July 23, 2020

Public Version Number

4

DI Record Publish Date

September 01, 2016

Additional Identifiers

Package DI Number

20887787007644

Quantity per Package

48

Contains DI Package

10887787007647

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