GUDID 00763000359355

CABLE 2035U ELECTRICAL UMBILICAL BMED

MEDTRONIC, INC.

Electrical-only medical device connection cable, single-use
Primary Device ID00763000359355
NIH Device Record Keyf7042527-f905-4e14-95fe-4fa9e6ff5545
Commercial Distribution StatusIn Commercial Distribution
Version Model Number2035U
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
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

Operating and Storage Conditions

Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000359355 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LPBCardiac ablation percutaneous catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-06
Device Publish Date2023-02-25

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