CUSTOM PACK CB7V41R1 4PK DELNIDO Medical Device Identification

GUDID 20643169323807

CUSTOM PACK CB7V41R1 4PK DELNIDO

MEDTRONIC, INC.

Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set Cardiopulmonary bypass system blood tubing set

Primary Device ID	20643169323807
NIH Device Record Key	f15fdced-156c-4523-8f96-de44c8ea700d
Commercial Distribution Discontinuation	2016-03-31
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	CB7V41R1
Company DUNS	006261481
Company Name	MEDTRONIC, INC.
Device Count	1
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	true
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	true
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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169323803 [Primary]
GS1	20643169323807 [Package] Contains: 00643169323803 Package: PK [4 Units] Discontinued: 2016-03-31 Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K891687

FDA Product Code

DTZ	OXYGENATOR, 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	2015-06-12

Devices Manufactured by MEDTRONIC, INC.

00763000897642 - Launcher™	2024-05-15 CATHETER LA6ALR12A LA 6F 110CM ALR12
00763000897659 - Launcher™	2024-05-15 CATHETER LA6AR10A LA 6F 110CM AR10
00763000897666 - Launcher™	2024-05-15 CATHETER LA6AR20A LA 6F 110CM AR20
00763000897673 - Launcher™	2024-05-15 CATHETER LA6AL30A LA 6F 110CM AL30
00763000897680 - Launcher™	2024-05-15 CATHETER LA6AL40A LA 6F 110CM AL40
00763000897697 - Launcher™	2024-05-15 CATHETER LA6HSIA LA 6F 110CM HSI
00763000897703 - Launcher™	2024-05-15 CATHETER LA6HSIIA LA 6F 110CM HSII
00763000897710 - Launcher™	2024-05-15 CATHETER LA6JCL40A LA 6F 110CM JCL40