| Primary Device ID | 00850041049236 |
| NIH Device Record Key | c8dc2cb9-54f4-407a-b3d5-301879d1baf4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Micro-OSMETTE Sample Tubes, 50 ul |
| Version Model Number | 2023 |
| Catalog Number | 2023 |
| Company DUNS | 001001676 |
| Company Name | Precision Systems, 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 | true |
| Lot Batch | false |
| Serial Number | false |
| 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 | 00850041049236 [Primary] |
| JJM | Osmometer For Clinical Use |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-23 |
| Device Publish Date | 2023-10-14 |
| 00850041049014 - Precision Systems 100 mOsm Osmometry Standard | 2023-10-23 Precision Systems 100 mOsm Osmometry Standard, 125 mL bottle |
| 00850041049021 - Precision Systems 200 mOsm Osmometry Standard | 2023-10-23 Precision Systems 200 mOsm Osmometry Standard, 250 mL bottle |
| 00850041049038 - Precision Systems 300 mOsm Osmometry Standard | 2023-10-23 Precision Systems 300 mOsm Osmometry Standard, 125 mL bottle |
| 00850041049045 - Precision Systems 400 mOsm Osmometry Standard | 2023-10-23 Precision Systems 400 mOsm Osmometry Standard, 250 mL bottle |
| 00850041049052 - Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle | 2023-10-23 Precision Systems 500 mOsm Osmometry Standard, 125 mL bottle |
| 00850041049069 - Precision Systems 600 mOsm Osmometry Standard | 2023-10-23 Precision Systems 600 mOsm Osmometry Standard, 250 mL bottle |
| 00850041049076 - Precision Systems 700 mOsm Osmometry Standard | 2023-10-23 Precision Systems 700 mOsm Osmometry Standard, 250 mL bottle |
| 00850041049083 - Precision Systems 800 mOsm Osmometry Standard | 2023-10-23 Precision Systems 800 mOsm Osmometry Standard, 250 mL bottle |