NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET - PUMP SEGMENT 8.0 mm PRIMING VOLUME 152 ML - NIPRO MEDICAL CORPORATION

Duns Number:797372554

Device Description: PUMP SEGMENT 8.0 mm PRIMING VOLUME 152 ML EQUIPMENT FRESENIUS 2008

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More Product Details

Catalog Number

BL+A210/V803

Brand Name

NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET

Version/Model Number

A210/V803

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

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

FJK

Product Code Name

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE

Device Record Status

Public Device Record Key

f3c53763-9fb7-41a8-8ae7-7ac58aef14ce

Public Version Date

June 07, 2019

Public Version Number

3

DI Record Publish Date

September 16, 2015

Additional Identifiers

Package DI Number

40383790004068

Quantity per Package

24

Contains DI Package

00383790004060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"NIPRO MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 230