CUSTOM PACK CB5J87R 10PK CARDIO 3IN Medical Device Identification

GUDID 20613994371793

CUSTOM PACK CB5J87R 10PK CARDIO 3IN

MEDTRONIC, INC.

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Primary Device ID	20613994371793
NIH Device Record Key	f5993d9a-d065-40bb-b3d9-bac062318e13
Commercial Distribution Discontinuation	2018-10-24
Commercial Distribution Status	Not in Commercial Distribution
Version Model Number	CB5J87R
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	00613994371799 [Primary]
GS1	20613994371793 [Package] Contains: 00613994371799 Package: PK [10 Units] Discontinued: 2018-10-24 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	4
Public Version Date	2018-12-13
Device Publish Date	2015-06-11

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