GUDID 20643169431618

CABLE 5846VL ROHS GLB 12FT 5PK 10L

MEDTRONIC, INC.

Electrical-only medical device connection cable, single-use
Primary Device ID20643169431618
NIH Device Record Keya4a8afc3-183f-464c-a40b-6a0e01e1e9f4
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5846VL
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet
Length12 Feet

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -40 Degrees Fahrenheit and 158 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169431621 [Primary]
GS120643169431618 [Package]
Contains: 00643169431621
Package: PK [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-06
Device Publish Date2014-12-08

Devices Manufactured by MEDTRONIC, INC.

00763000300623 - N/A2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM
00763000596958 - InterStim™ SureScan™2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL
00763000596996 - InterStim™ SureScan™2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL
00763000994198 - N/A2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR
00199150065684 - NA2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM
00199150065691 - NA2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E
00199150065745 - NA2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED
20199150065763 - NA2026-01-06 CUSTOM PACK BB11V27R2 10PK ACC 3/8 CONN

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.