GUDID 00763000812058

SERVICE KIT 5873C LEAD MDR

MEDTRONIC, INC.

Pacing/defibrillation lead repair kit
Primary Device ID00763000812058
NIH Device Record Key2462378f-d57f-4331-b753-e3f45c37b202
Commercial Distribution StatusIn Commercial Distribution
Version Model Number5873C
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 Kittrue
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000812058 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NVZPulse generator, permanent, implantable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-21
Device Publish Date2025-04-12

Devices Manufactured by MEDTRONIC, INC.

00199150007172 - NA2025-04-21 CUSTOM PACK PDBB11V44R10 CORE PIX
00199150007547 - NA2025-04-21 CUSTOM PACK SSBB10Z49R20 NEW CONFIG
00763000812041 - NA2025-04-21 CAP 5867-3M STERILE MDR
00763000812058 - NA2025-04-21SERVICE KIT 5873C LEAD MDR
00763000812058 - NA2025-04-21 SERVICE KIT 5873C LEAD MDR
00763000947064 - Bio-Medicus™2025-04-21 CANNULA 96530-115 BIO-MEDICUS 15FR
00763000947071 - Bio-Medicus™2025-04-21 CANNULA 96530-117 BIO-MEDICUS 17FR
00763000947088 - Bio-Medicus™2025-04-21 CANNULA 96530-119 BIO-MEDICUS 19FR
00763000947095 - Bio-Medicus™2025-04-21 CANNULA 96530-121 BIO-MEDICUS 21FR

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