| Primary Device ID | 00612649165769 |
| NIH Device Record Key | d629f805-3553-4e3f-914b-be8b51f31e90 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | DISPOSABLE XENON KITFOR NUCLEAR MEDICINE |
| Version Model Number | 20035 |
| Catalog Number | 20035 |
| Company DUNS | 009299017 |
| Company Name | King Systems Corporation |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com | |
| Phone | +14107686464 |
| Purchase_orders@ambuUSA.com |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00612649165769 [Package] Contains: 00612649185293 Package: [20 Units] In Commercial Distribution |
| GS1 | 00612649185293 [Primary] |
| IYT | System, rebreathing, radionuclide |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-21 |
| 00612649165769 | XENON CIRCUT 20/CS |
| 00612649101903 | XENON CIRCUIT |