GRI-BAG - GRI-BAG is a single-use, non-pyrogenic flexible - LABORATORIOS GRIFOLS SA

Duns Number:463720681

Device Description: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filter. It is supplied sterile in sealed peel-pack pouches and isavailable in volume capacities of 100 ml, 250 ml, 500 ml and 1000 ml. The GRI-BAG models have a twist-off valve output connector whereas the GRIBAGAP models have a conus vial output connector.

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More Product Details

Catalog Number

-

Brand Name

GRI-BAG

Version/Model Number

500 AP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2021

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

K033916,K033916

Product Code Details

Product Code

FPB

Product Code Name

Filter, Infusion Line

Device Record Status

Public Device Record Key

cb49c99e-1e13-43e9-b0c6-a0b11754561e

Public Version Date

October 26, 2021

Public Version Number

5

DI Record Publish Date

April 05, 2017

Additional Identifiers

Package DI Number

28426314580827

Quantity per Package

20

Contains DI Package

08426314580823

Package Discontinue Date

October 18, 2021

Package Status

Not in Commercial Distribution

Package Type

box

"LABORATORIOS GRIFOLS SA" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 15