| Primary Device ID | 10718175005245 |
| NIH Device Record Key | a05b94b2-d5e9-48a3-bbd8-0c8ca6b9e2f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | XENON CONVENIENCE KITS |
| Version Model Number | 134-772 |
| Catalog Number | 134-772 |
| Company DUNS | 043833813 |
| Company Name | BIODEX MEDICAL 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 | true |
| Serial Number | false |
| 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 | 00718175005248 [Primary] |
| GS1 | 10718175005245 [Package] Contains: 00718175005248 Package: Box [25 Units] In Commercial Distribution |
| IYT | System, Rebreathing, Radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2019-12-13 |
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| 00718175001462 - Biodex | 2023-08-10 CYCLE, UPPER BODY |
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| 00718175087640 - BETA, Syringe Shield | 2021-01-15 BETA, Lead Encapsulated Syringe Shield, 20cc |
| 00718175087626 - VENTI-SCAN IV | 2020-10-23 Venti-Scan IV, Includes shielded canister with IV pole mount |