GUDID 00643169100961

KIT 8543 ISOMED CATH ACCESS PORT PF

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use
Primary Device ID00643169100961
NIH Device Record Key18684b06-a5cd-4869-a79c-935ac3ffee8f
Commercial Distribution StatusIn Commercial Distribution
Version Model Number8543
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169100961 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2014-09-23

Devices Manufactured by MEDTRONIC, INC.

00199150023714 - NA2025-06-20 CUSTOM PACK BB11X44R6 3/16X1/4 NEO
20199150024364 - NA2025-06-20 CUSTOM PACK BB9Q89R2 10PK 10PK 1/4
00199150024377 - NA2025-06-20 CUSTOM PACK BB10J06R16 3/8 E C L S
20199150024418 - NA2025-06-20 CUSTOM PACK BB11M93R1 4PK 1/4 E
20199150025378 - NA2025-06-20 CUSTOM PACK BB12A48R2 5PK Y PIGTAILS
20199150025408 - NA2025-06-20 CUSTOM PACK BB11M89R1 4PK 3/8E
00199150025855 - NA2025-06-20 CUSTOM PACK BB6T48R18 PEDS V
00199150025862 - NA2025-06-20 CUSTOM PACK BB12C61R2 TBL W PMPHEAD

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