GRI-BAG

GUDID 28426314604035

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 is available 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 GRIBAG AP models have a conus vial output connector.

LABORATORIOS GRIFOLS SA

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• Primary Device ID: 28426314604035
• NIH Device Record Key: 0121346f-28c4-4076-84cd-6bdcf09ec2ff
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GRI-BAG
• Version Model Number: 250
• Company DUNS: 463720681
• Company Name: LABORATORIOS GRIFOLS SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08426314604031 [Primary]
GS1	28426314604035 [Package]; Contains: 08426314604031; Package: box [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K033916

FDA Product Code

• FPB: Filter, Infusion Line

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-04-05

On-Brand Devices [GRI-BAG]

• 28426314604035: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 08426314604024: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314583507: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 08426314580823: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314580810: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 08426314575690: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 08426314575683: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314546830: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314391485: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314391478: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314391416: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte
• 28426314391393: GRI-BAG is a single-use, non-pyrogenic flexible empty container with incorporated 0.2 µ.m filte