| Primary Device ID | 00627825011761 |
| NIH Device Record Key | 31cfe6c7-f962-4aee-aaa8-88301cd45dae |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PIM NXT for Fluid |
| Version Model Number | PIX2231 |
| Company DUNS | 203383526 |
| Company Name | Laborie Medical Technologies Canada ULC |
| 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 | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
|---|---|
| GS1 | 00627825011761 [Primary] |
| FEN | Device, Cystometric, Hydraulic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-12 |
| Device Publish Date | 2021-08-04 |
| 30627825007024 - Extension Set 2 | 2022-07-04 |
| 20627825007294 - Extension Line, 60 cm | 2022-07-04 |
| 20627825007317 - Extension Line, 1500mm | 2022-07-04 |
| 20627825007324 - Extension Line, 15cm | 2022-07-04 |
| 20627825007348 - Extension Line, 150cm Blue | 2022-07-04 |
| 30627825007352 - Extension Line, 150cm Yellow | 2022-07-04 |
| 20627825007034 - Extension Set 3 | 2022-07-04 |
| 30627825007307 - Extension Line, 90 cm | 2022-07-04 |