| Primary Device ID | 16970057578429 |
| NIH Device Record Key | 0da53ecf-5b25-4632-8e07-5e09f73139d4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Balloon Inflators |
| Version Model Number | VDK-IF-12 |
| Company DUNS | 544430136 |
| Company Name | Jiangsu Vedkang Medical Science and Technology Co.,Ltd. |
| 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 | true |
| 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 | 06970057578422 [Primary] |
| GS1 | 16970057578429 [Package] Contains: 06970057578422 Package: BOX [1 Units] In Commercial Distribution |
| GS1 | 56970057578427 [Package] Package: carton [5 Units] In Commercial Distribution |
| PTM | Syringe, Balloon Inflation, Exempt |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-28 |
| Device Publish Date | 2024-08-20 |