| Primary Device ID | B461JAU11681 |
| NIH Device Record Key | 24125c43-f418-4c9e-b899-2c5b4a9bef2a |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Jac-cell USA Inc. |
| Version Model Number | JAU-1168 |
| Company DUNS | 015023538 |
| Company Name | JAC CELL USA INC |
| Device Count | 10 |
| 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 |
|---|---|
| HIBCC | B461JAU116809 [Unit of Use] |
| HIBCC | B461JAU11681 [Primary] |
| BYY | Tube, Aspirating, Flexible, Connecting |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-02-27 |
| B461JAU97971 | SAF-T-VAC Smoke and Fluid Evacuator |
| B461JAU3092R0 | Reusable Push Button Pencil With Stamping Blade ,3M Cable |
| B461JAU15201 | Disposal standard blade electrode |
| B461JAU142213 | PENCIL, Push Button w/SS Blade&Holster Disposable |
| B461JAU117013 | INFILTRATION TUBING FOR PERISTALTIC PUMP WITH 2 SPIKES |
| B461JAU11681 | Infiltration tubing for peristaltic pumps |