| Primary Device ID | 10627825000359 |
| NIH Device Record Key | 79112c10-c59e-466e-adf1-34e8c8180dbe |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Abdominal Pressure Catheter 9F |
| Version Model Number | ERPC-9 |
| 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 | 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 | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00627825000352 [Primary] |
| GS1 | 10627825000359 [Package] Contains: 00627825000352 Package: [10 Units] In Commercial Distribution |
| GS1 | 20627825000356 [Package] Package: [1500 Units] In Commercial Distribution |
| FEN | DEVICE, CYSTOMETRIC, HYDRAULIC |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[10627825000359]
Ethylene Oxide
[10627825000359]
Ethylene Oxide
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-09-21 |
| 20627825000387 | RPC-9 |
| 10627825000366 | RPC-9 |
| 10627825000359 | ERPC-9 |