| Primary Device ID | 07290008325066 |
| NIH Device Record Key | 478a1c39-98fb-4570-b555-546aa039a695 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NIO |
| Version Model Number | NIO-I |
| Company DUNS | 514619238 |
| Company Name | WaisMed Ltd |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290008325066 [Primary] |
| GS1 | 17290008325063 [Package] Package: [12 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-11-19 |
| Device Publish Date | 2019-11-11 |
| 17290008325056 | The NIO-A device is indicated to provide intraosseous access into the proximal tibia and proxima |
| 17290008325025 | The Pediatric NIO device is indicated to provide intraosseous access in the proximal tibia as an |
| 07290008325066 | The NIO-Infant (NIO-I) is an intraosseous device intended to provide vascular access in the prox |
| 07290008325080 | The NIO Pediatric device is indicated to provide intraosseous access in the proximal tibia as an |