| Primary Device ID | 00850004162040 |
| NIH Device Record Key | 7db52b15-426f-4ca2-bc7a-9aa3f8617864 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | INFLATION DEVICE |
| Version Model Number | VGAI25C |
| Catalog Number | VGAI25C |
| Company DUNS | 050193715 |
| Company Name | VALFLUX GROUP, LLC |
| 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 | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Phone | +556230916442 |
| regulacao@valflux.com.br |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850004162040 [Primary] |
| MAV | Syringe, balloon inflation |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2020-05-06 |
| Device Publish Date | 2018-12-19 |
| 00850004162040 - INFLATION DEVICE | 2020-05-06VGAI25C INFLATION DEVICE |
| 00850004162040 - INFLATION DEVICE | 2020-05-06 VGAI25C INFLATION DEVICE |
| 00850004162125 - INTRODUCER SET | 2019-06-07 VGCTR03 INTRODUCER SET |
| 00850004162132 - INTRODUCER SET | 2019-06-07 VGCTR03A INTRODUCER SET |
| 00850004162149 - INTRODUCER SET | 2019-06-07 VGCTR04 INTRODUCER SET |
| 00850004162156 - INTRODUCER SET | 2019-06-07 VGCTR04A INTRODUCER SET |
| 00850004162163 - INTRODUCER SET | 2019-06-07 VGHIS00 INTRODUCER SET |
| 00850004162170 - INTRODUCER SET | 2019-06-07 VGHIS01 INTRODUCER SET |
| 00850004162187 - INTRODUCER SET | 2019-06-07 VGHIS02 INTRODUCER SET |