GRI-BAG
GUDID 08426314604024
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
Compounding transfer set| Primary Device ID | 08426314604024 |
| NIH Device Record Key | 2d3326a6-0a90-4287-9126-9cb4a8db910e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GRI-BAG |
| Version Model Number | 250 AP |
| 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 | 08426314604024 [Primary] |
| GS1 | 28426314604028 [Package] Package: box [20 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K033916
FDA Product Code
| KPE | Container, I.V. |
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 |
Trademark Results [GRI-BAG]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GRI-BAG 78237850 2973202 Live/Registered |
GRIFOLS, S.A. 2003-04-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.