TUBING 1S85R1 5PK AFFY SMPLNG MNFOLD SET Medical Device Identification

GUDID 20721902834244

TUBING 1S85R1 5PK AFFY SMPLNG MNFOLD SET

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	20721902834244
NIH Device Record Key	1029825e-ab7b-4b92-84ed-6cf055ef5ba8
Commercial Distribution Status	In Commercial Distribution
Version Model Number	1S85R1
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	false
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

Operating and Storage Conditions

Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00721902834240 [Primary]
GS1	20721902834244 [Package] Contains: 00721902834240 Package: PK [5 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K800178

FDA Product Code

DWE	TUBING, PUMP, 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	2016-05-22

Devices Manufactured by MEDTRONIC, INC.

20763000770291 - TrailBlazer™	2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
20763000770307 - TrailBlazer™	2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
20763000770314 - TrailBlazer™	2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
20763000770321 - TrailBlazer™	2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
20763000770338 - TrailBlazer™	2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
20763000770345 - TrailBlazer™	2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
20763000770352 - TrailBlazer™	2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04
20763000770369 - TrailBlazer™	2024-07-16 PS ASC-035-090 TRAILBLAZER ANGLED V04