| 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 |
| 00821925045989 - Olympus | 2025-04-17 nCare 4K Cable, DisplayPort to HDMI, 6ft or (1.83 m), C2G, 54326 |
| 00821925045996 - Olympus | 2025-04-17 nCare 4K Cable Assembly, 1694F, 3G-SDI, 4K BNC Male to Male, 6 ft. or (1.83 m), Black |
| 00821925046610 - Olympus | 2025-04-17 nCare 4K Keyboard, All-in-one, Compact, Medical, Washable, USB, White |
| 00821925047075 - Olympus | 2025-04-17 nCare 4K Footswitch |
| 00821925047082 - Olympus | 2025-04-17 nCare 4K Audio Cables |
| 00821925045941 - Olympus | 2025-04-16 nCare 4K 21.5" Medical Touch Panel |
| 00821925045958 - Olympus | 2025-04-16 nCare 4K Cable Assembly, DVI-D to DVI-D, Single Link TMDS, Black, 6.0 ft. or (1.83 m) |
| 00821925045965 - Olympus | 2025-04-16 nCare 4K Cable Assembly, HDMI M to DVI-D M, Single Link, Black, 6 ft. or (1.83 m) |