SURG KIT TK2 BLOOD PROCES W/225BOWL 6PK Medical Device Identification

GUDID 20613994520368

SURG KIT TK2 BLOOD PROCES W/225BOWL 6PK

MEDTRONIC, INC.

Blood-processing autotransfusion system set

Primary Device ID	20613994520368
NIH Device Record Key	06ef9589-480e-44a1-9af5-36aa8070be2a
Commercial Distribution Status	In Commercial Distribution
Version Model Number	TK2
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	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	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
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
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
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
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 Dimensions

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Operating and Storage Conditions

Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius
Special Storage Condition, Specify	Between 0 and 0 *Store in a dry place away from extremes of temperature.
Storage Environment Temperature	Between 0 Degrees Celsius and 50 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994520364 [Primary]
GS1	20613994520368 [Package] Contains: 00613994520364 Package: PK [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K812292

FDA Product Code

CAC	APPARATUS, AUTOTRANSFUSION

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	2015-06-09

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