| Primary Device ID | B0745000090 |
| NIH Device Record Key | 83bacfbf-2f91-475e-9dbc-f57df5fc8042 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NEPHROCHECK Calibration Verification (Cal Vers) Ki |
| Version Model Number | 500009 |
| Catalog Number | 500009 |
| Company DUNS | 942854212 |
| Company Name | ASTUTE MEDICAL, INC. |
| 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 | true |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B0745000090 [Primary] |
| PIG | Acute Kidney Injury Test System |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-12 |
| B0744000160 - ASTUTE140 Electronic Quality Control (EQC) Device | 2018-03-29 |
| B0745000090 - NEPHROCHECK Calibration Verification (Cal Vers) Ki | 2018-03-29The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System. |
| B0745000090 - NEPHROCHECK Calibration Verification (Cal Vers) Ki | 2018-03-29 The NEPHROCHECK Calibration Verification (Cal Vers) Materials are to verify calibration of the NEPHROCHECK Test System. |
| B0745000110 - NEPHROCHECK Test Kit | 2018-03-29 The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who curren |
| B0745000130 - NEPHROCHECK Liquid Control Kit | 2018-03-29 The NEPHROCHECK Liquid Controls are used for the quality control monitoring of the NEPHROCHECK Test System. |
| B0745000170 - ASTUTE140 Meter Kit | 2018-03-29 |