| Primary Device ID | 00821925041844 |
| NIH Device Record Key | 76a8473f-fe89-4f4c-a0c6-99b07b74ab77 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BROOKS DISTEN-U-FLO |
| Version Model Number | GY5-TUB |
| Company DUNS | 007198742 |
| Company Name | Gyrus ACMI, 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 | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00821925002456 [Package] Package: [12 Units] In Commercial Distribution |
| GS1 | 00821925041844 [Primary] |
| GAZ | Tubing, Noninvasive |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-02 |
| Device Publish Date | 2024-11-22 |
| 00810008184615 - Olympus | 2025-01-30 ES-IP Base IN-ROOM System with Optional Equipment |
| 00810008185131 - Olympus | 2025-01-30 ES-IP BASE SWIVEL IN-ROOM with Optional Equipment |
| 00810008185148 - Olympus | 2025-01-30 ES-IP BASE SYSTEM, SPLIT RACK, TWO ROOM with Optional Equipment |
| 00810008185155 - Olympus | 2025-01-30 ES-IP BASE SYSTEM, SPLIT RACK, THREE ROOM with Optional Equipment |
| 00810008185162 - Olympus | 2025-01-30 ES-IP BASE SYSTEM, SPLIT RACK, FREESTANDING OPTION with Optional Equipment |
| 00810008185261 - Olympus | 2025-01-30 ES-IP Dual IN-ROOM System with Optional Equipment |
| 00810008185278 - Olympus | 2025-01-30 ES-IP EXPANDED IN-ROOM System 25RU with Optional Equipment |
| 00810008185759 - Olympus | 2025-01-30 ES-IP Dual IN-ROOM System - Expanded with Optional Equipment |