Primary Device ID | 00613994546180 |
NIH Device Record Key | 8ffcc8e3-82d9-48fe-81ac-2b5e55cb55d7 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | PACEART® SYSTEM ECG MODULE |
Version Model Number | P127TUV |
Company DUNS | 006261481 |
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 | false |
Lot Batch | false |
Serial Number | true |
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 |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 150 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00613994546180 [Primary] |
DPS | Electrocardiograph |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-11-04 |
Device Publish Date | 2019-10-25 |
00199150031610 - NA | 2025-07-21 CUSTOM PACK BB1U06R24 CHRIS AD |
00199150032464 - NA | 2025-07-21 CUSTOM PACK BB10R35R4 CP PRIME |
20199150032482 - NA | 2025-07-21 CUSTOM PACK 6S19R4 10PK DIALYSIS |
00199150033423 - NA | 2025-07-21 CUSTOM PACK BB12B90R7 SPECTRU |
20199150033571 - NA | 2025-07-21 CUSTOM PACK BB2U59R3 2PK 1/4 TBL L |
00199150033614 - NA | 2025-07-21 CUSTOM PACK BB10J74R14 3/8CNTRIS |
00199150034246 - NA | 2025-07-21 CUSTOM PACK BB11J86R12 ADULT E |
00763000925093 - FlexCath Cross™ Transseptal Solution | 2025-07-21 NDL 900302 FLEXCATH CROSS SL 63CM EIFU |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PACEART 87252084 5195774 Live/Registered |
Medtronic, Inc. 2016-11-30 |
![]() PACEART 74074454 1650680 Live/Registered |
Paceart, Inc. 1990-07-02 |