GUDID 20643169014033

INTRDCR 206211A 10PK 6F 11CM INPT OBT

MEDTRONIC, INC.

Vascular catheter introduction set, nonimplantable
Primary Device ID20643169014033
NIH Device Record Keyf96ce3a5-4521-467b-bf35-cb7dff5603d3
Commercial Distribution StatusIn Commercial Distribution
Version Model Number206211A
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

Device Dimensions

Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French
Length11 Centimeter
Catheter Gauge6 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169014039 [Primary]
GS120643169014033 [Package]
Contains: 00643169014039
Package: PK [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYBINTRODUCER, CATHETER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-06-07
Device Publish Date2017-02-02

Devices Manufactured by MEDTRONIC, INC.

00199150000296 - NA2025-03-14 CUSTOM PACK BB10R33R2 WHLG SUPT
00199150000302 - NA2025-03-14 CUSTOM PACK BB12D68R1 1/4 DAV PK
20199150000320 - NA2025-03-14 CUSTOM PACK BB10V15R5 5PK SUPP
20199150000344 - NA2025-03-14 CUSTOM PACK BB8S27R1 5PK Y LINE CB
20199150000368 - NA2025-03-14 CUSTOM PACK BB11P52R1 5PK Y LINE CB
00199150000616 - NA2025-03-14 CUSTOM PACK BB11N74R15 CCS-ST MARKS
00199150000623 - NA2025-03-14 CUSTOM PACK BB7E57R18 PUMP
00199150000630 - NA2025-03-14 CUSTOM PACK BB11B96R4 HEART PACK
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.