| 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 |
| 00810008184943 - Olympus | 2025-09-29 ES-IP HD PTZ CAMERA KIT |
| 00810008185018 - Olympus | 2025-09-29 ES-IP 4K-SDI CXN |
| 00810008185032 - Olympus | 2025-09-29 ES-IP NEC M651 65" DISPLAY WALL |
| 00810008185063 - Olympus | 2025-09-29 ES-IP DVI/HDMI OUTPUT |
| 00821925047150 - Olympus | 2025-09-29 ES-IP DUAL IN-ROOM System - EXPANDED 48U |
| 00821925047242 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg ER (with rack) |
| 00821925047259 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg ER (no rack) |
| 00821925047266 - Olympus | 2025-09-29 ES-IP iOR BWK Hamburg OP (with rack) |