| Primary Device ID | 00850031859036 |
| NIH Device Record Key | 9233636d-1f06-4460-a122-14937fadac03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Galvanize Cart |
| Version Model Number | GTI-00076 |
| Company DUNS | 070000990 |
| Company Name | Galvanize Therapeutics, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850031859036 [Primary] |
| BZN | Cart, Emergency, Cardiopulmonary (Excluding Equipment) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-30 |
| Device Publish Date | 2026-01-22 |
| 00850031859036 - Galvanize Cart | 2026-01-30Galvanize Cart |
| 00850031859036 - Galvanize Cart | 2026-01-30 Galvanize Cart |
| 00850031859074 - INUMI Flex Needle | 2025-03-10 INUMI Flex Needle, 5 pack |
| 00850031859104 - Aliya Generator-Recertified | 2025-03-10 Aliya Generator - recertified |
| 00850031859043 - Aliya Generator | 2025-03-03 Aliya Generator, 2.5 |
| 10850031859002 - Aliya Needle | 2024-02-29 Aliya Needle, 5 pack |
| 10850031859026 - Aliya Electrode | 2024-02-29 Aliya Electrode, 5 pack |
| 00850031859050 - Aliya Generator | 2023-08-28 Aliya Generator, 2.5 |