| Primary Device ID | 00628101609870 |
| NIH Device Record Key | 08da9fa5-de3d-4d21-8252-e810498eee22 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Legacy Flowmeter |
| Version Model Number | FM-LT15NA |
| Company DUNS | 005192885 |
| Company Name | OHIO MEDICAL, LLC |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM | |
| Phone | 1 847 855 0500 |
| CUSTOMER.SERVICE@OHIOMEDICAL.COM |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00628101609870 [Primary] |
| CAX | Flowmeter, Tube, Thorpe, Back-Pressure Compensated |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-09-14 |
| Device Publish Date | 2020-09-04 |
| 00628101609955 | FM-LT series, 3 LPM, CHINA, OXYGEN, LEGACY |
| 00628101609948 | FM-LT series, 15 LPM, IRS, OXYGEN, LEGACY |
| 00628101609931 | FM-T series, 15 LPM, 500kPa, AIR, LEGACY |
| 00628101609924 | FM-T series, 3 LPM, 500kPa, OXYGEN, LEGACY |
| 00628101609917 | FM-T series, 15 LPM, 500kPa, OXYGEN, LEGACY |
| 00628101609900 | FM-T series, 15 LPM, USA, AIR, LEGACY |
| 00628101609894 | FM-T series, 3 LPM, USA, OXYGEN, LEGACY |
| 00628101609887 | FM-T series, 15 LPM, USA, OXYGEN, LEGACY |
| 00628101609863 | FM-T series, 3 LPM, 414kPa, OXYGEN, LEGACY |
| 00628101609856 | FM-T series, 15 LPM, 414kPa, OXYGEN, LEGACY |
| 00628101609849 | FM-T series, 15 LPM, ISO, AIR, LEGACY |
| 00628101609832 | FM-T series, 3 LPM, ISO, OXYGEN, LEGACY |
| 00628101609825 | FM-T series, 15 LPM, ISO, OXYGEN, LEGACY |
| 00628101609870 | FM-T series, 15 LPM, 414kPa, AIR, LEGACY |