GUDID 20643169352784

CABLE 203CXC COAXIAL UMBIL BOX 12 ROHS

MEDTRONIC, INC.

Liquid nitrous oxide coaxial tubing
Primary Device ID20643169352784
NIH Device Record Key69648f07-7e87-4b6c-9b3c-b627e38744c7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number203CXC
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count12
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

Operating and Storage Conditions

Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -31 Degrees Fahrenheit and 136 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep Dry
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169352780 [Unit of Use]
GS120643169352784 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-05-08

Devices Manufactured by MEDTRONIC, INC.

00199150057177 - NA2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY
00199150058976 - NA2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT
00199150060122 - NA2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK
00763000849801 - Liberant™2025-11-24 CONSOLE LMT-BCU LIBERANT
00763000913069 - InterStim™ SureScan™2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08
00763000913083 - InterStim™ SureScan™2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08
00763000913106 - InterStim™ SureScan™2025-11-24 LEAD 978A141 ISTM 2.16MM EMAN EUMDR LI08
00763000913120 - InterStim™ SureScan™2025-11-24 LEAD 978B128 ISTM 4.32MM EUMDR EMAN LI08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.