GUDID 00763000825522

REV KIT 8578 PUMP CONNCTR EMAN

MEDTRONIC, INC.

Lumbar cerebrospinal fluid drainage catheterization kit
Primary Device ID00763000825522
NIH Device Record Key6bfd61e2-3702-4d01-b0ef-c62c7a926d7e
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8578
Company DUNS796986144
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 Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000825522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPump, infusion, implanted, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-18
Device Publish Date2023-12-09

Devices Manufactured by MEDTRONIC, INC.

20199150061970 - NA2025-12-08 CUSTOM PACK BB12R02R3 5PK ACC STRNG SUC
00199150062027 - NA2025-12-08 CUSTOM PACK BB12R85R AVL 3/8 ECCPK
20199150062229 - NA2025-12-08 CUSTOM PACK BB1Q47R3 5PK ACC TABLE
20199150062243 - NA2025-12-08 CUSTOM PACK BB12R66R 20PK ACC 1/4 W/LL
20199150062960 - NA2025-12-08 CUSTOM PACK BB9R13R15 4PK CPN PLEG PACK
00643169265691 - NA2025-12-08 LEAD ACC KIT 6056M GLOBAL 17L NEW ACI
00199150060467 - NA2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC
00199150060627 - NA2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS

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