| Primary Device ID | 00840155411005 |
| NIH Device Record Key | 9a8c862b-cd23-40ad-8f0c-079e1b219306 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Smith's Catheters |
| Version Model Number | SM-84426 |
| Catalog Number | Not Applicable |
| Company DUNS | 041674552 |
| Company Name | MEDSOURCE INTERNATIONAL LLC |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00840155410992 [Primary] |
| GS1 | 00840155411005 [Package] Contains: 00840155410992 Package: Box [50 Units] In Commercial Distribution |
| GS1 | 00840155411012 [Package] Contains: 00840155410992 Package: Case [200 Units] In Commercial Distribution |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-08-23 |
| Device Publish Date | 2021-08-13 |