CANNULA KIT DLP3D76R1 5PK MASTER Medical Device Identification

GUDID 20721902835821

CANNULA KIT DLP3D76R1 5PK MASTER

MEDTRONIC, INC.

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Primary Device ID	20721902835821
NIH Device Record Key	ea20cf09-2960-4e89-9547-e4cb67544bf9
Commercial Distribution Status	In Commercial Distribution
Version Model Number	DLP3D76R1
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	5
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902835827 [Unit of Use]
GS1	20721902835821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K924529

FDA Product Code

DWF	CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2016-06-05

Devices Manufactured by MEDTRONIC, INC.

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00763000902544 - Launcher™	2024-06-04 CATHETER LA83DRCSH LA 8F 100CM 3DRC
00763000902551 - Launcher™	2024-06-04 CATHETER LA83DRCSHD LA 8F 90CM 3DRC
00763000902568 - Launcher™	2024-06-04 CATHETER LA83DRIGHT LA 8F 100CM 3DRGT
00763000902575 - Launcher™	2024-06-04 CATHETER LA83DRIGHTD LA 8F 90CM 3DRGT
00763000902582 - Launcher™	2024-06-04 CATHETER LA8AL10 LA 8F 100CM AL10
00763000902599 - Launcher™	2024-06-04 CATHETER LA8AL10D LA 8F 90CM AL10
00763000902605 - Launcher™	2024-06-04 CATHETER LA8AL10F LA 8F 80CM AL10