| Primary Device ID | 00718175003329 |
| NIH Device Record Key | e2fb56f7-c4aa-48d1-a48f-6b80b1900572 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Atomlab 500 Plus |
| Version Model Number | 086-332 |
| Catalog Number | 086-332 |
| Company DUNS | 043833813 |
| Company Name | BIODEX MEDICAL SYSTEMS, INC. |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 | 00718175003329 [Primary] |
| KPT | Calibrator, Dose, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-11-02 |
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| 00718175087626 - VENTI-SCAN IV | 2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount |