| Primary Device ID | 00792079000035 |
| NIH Device Record Key | c490b623-47bd-416c-8498-318d93308e69 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Peritoneal Dialysis Catheter |
| Version Model Number | SA-1248K |
| Catalog Number | SA-1248K |
| Company DUNS | 241421320 |
| Company Name | Medionics International 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 | 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | 905-472-6544 |
| info@medionics.com | |
| Phone | 905-472-6544 |
| info@medionics.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00792079000035 [Primary] |
| FJS | Catheter, Peritoneal, Long-Term Indwelling |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2018-04-09 |
| 00792079001674 | SA-1255 |
| 00792079001476 | PSNA-100 |
| 00792079000967 | SNCA-5263LFD |
| 00792079000592 | SNPS-53113 |
| 00792079000363 | SNCP-5243L |
| 00792079000356 | SNCA-5262L |
| 00792079000264 | CP-1241 |
| 00792079000226 | CA-1157 |
| 00792079000219 | CA-1162 |
| 00792079000196 | CA-2262 |
| 00792079000141 | SI-1231 |
| 00792079000035 | SA-1248K |
| 00792079000028 | SA-1247 |