Primary Device ID | 00643169230859 |
NIH Device Record Key | 4d21e36d-1319-458e-a63c-a203b1eb5acb |
Commercial Distribution Status | In Commercial Distribution |
Version Model Number | 5392 |
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 | |
Phone | +1(800)633-8766 |
Corporate.UDI@medtronic.com |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Storage Environment Temperature | Between -40 Degrees Fahrenheit and 158 Degrees Fahrenheit |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00643169230859 [Primary] |
DTE | PULSE-GENERATOR, PACEMAKER, EXTERNAL |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 4 |
Public Version Date | 2018-10-05 |
Device Publish Date | 2014-09-23 |
20763000980096 - NA | 2025-08-25 IMPEDANCE PATCH AFR-00015 |
20763000980119 - NA | 2025-08-25 MAGNETIC PATCH AFR-00021 |
00199150039371 - NA | 2025-08-22 CUSTOM PACK BB11U72R1 P/T |
00199150040872 - NA | 2025-08-22 CUSTOM PACK BB4K95R22 HLO PERFNPLEG |
00199150041145 - NA | 2025-08-22 CUSTOM PACK BB12Q87R1 HLN VAMC NASH |
00199150041978 - NA | 2025-08-22 CUSTOM PACK BB10F40R2 ACCESORY |
00199150041299 - NA | 2025-08-19 CUSTOM PACK BB8E60R12 EVL PED E |
20199150041118 - NA | 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE |