Primary Device ID | 00681490184311 |
NIH Device Record Key | 9ff57a6e-3098-4d80-8d4c-7505ac4e1b45 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | ISOMED ® |
Version Model Number | 8553 |
Company DUNS | 796986144 |
Company Name | MEDTRONIC, 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 | false |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00681490184311 [Primary] |
LKK | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2014-09-23 |
00199150016716 - NA | 2025-06-02 CUSTOM PACK BB8H19R2 ASSIST |
20199150019605 - NA | 2025-06-02 CUSTOM PACK BB9E36R2 5PK PACK 3 |
00199150019854 - NA | 2025-06-02 CUSTOM PACK BB11M65R2 ADULT ECC 1/4 |
00199150019861 - NA | 2025-06-02 CUSTOM PACK BB12B99R7 1/4 CENTRI PK |
20199150019889 - NA | 2025-06-02 CUSTOM PACK BB11Q69R1 10PK ANH PACK |
00199150019892 - NA | 2025-06-02 CUSTOM PACK BB8S58R4 3/8 SUPP |
00199150019908 - NA | 2025-06-02 CUSTOM PACK BB8T55R4 1/4 SUPP |
00199150019915 - NA | 2025-06-02 CUSTOM PACK BB5227R13 ASSIST |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ISOMED 77362690 3495293 Dead/Cancelled |
Fishel, Mark A 2008-01-02 |
![]() ISOMED 75458290 2300819 Live/Registered |
Medtronic, Inc. 1998-03-27 |
![]() ISOMED 74564312 not registered Dead/Abandoned |
Power Quality, Inc. 1994-08-22 |
![]() ISOMED 74503156 not registered Dead/Abandoned |
Medtronic, Inc. 1994-03-17 |