| Primary Device ID | 30351688081975 |
| NIH Device Record Key | d035751d-aada-4b0d-853c-cd17c28d4c3c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Jelco |
| Version Model Number | 328300 |
| Company DUNS | 146235697 |
| Company Name | SMITHS MEDICAL ASD, 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 | true |
| 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 | 10351688081971 [Primary] |
| GS1 | 30351688081975 [Package] Contains: 10351688081971 Package: BOX [50 Units] In Commercial Distribution |
| GS1 | 50351688081979 [Package] 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 | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2024-09-12 |
| Device Publish Date | 2016-11-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() JELCO 97501738 not registered Live/Pending |
JELCO, INC 2022-07-13 |
![]() JELCO 88904643 not registered Live/Pending |
Smiths Medical ASD, Inc. 2020-05-07 |
![]() JELCO 88477098 not registered Live/Pending |
J. E. LORTIE COMPANY LIMITED 2019-06-17 |
![]() JELCO 81001492 1001492 Dead/Cancelled |
Johnson & Johnson 0000-00-00 |
![]() JELCO 77770940 3746512 Live/Registered |
Smiths Medical ASD, Inc. 2009-06-30 |
![]() JELCO 75242787 2172522 Dead/Cancelled |
JELCO, INC. 1997-02-18 |
![]() JELCO 73130068 1085415 Live/Registered |
JOHNSON & JOHNSON 1977-06-13 |
![]() JELCO 72438236 0979039 Live/Registered |
JOHNSON & JOHNSON 1972-10-13 |
![]() JELCO 72211073 0797327 Live/Registered |
JOHNSON & JOHNSON 1965-02-01 |
![]() JELCO 72166482 0767143 Dead/Expired |
PETRI-KINE CAMERA COMPANY, INC. 1963-04-10 |