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.
Catalog Number
-
Brand Name
GRI-BAG
Version/Model Number
1000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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,K033916
Product Code
FPB
Product Code Name
Filter, Infusion Line
Public Device Record Key
126c42be-6695-421a-ab05-e67ceb138d10
Public Version Date
November 03, 2021
Public Version Number
1
DI Record Publish Date
October 26, 2021
Package DI Number
28426314391485
Quantity per Package
15
Contains DI Package
08426314391481
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 15 |