ASSY BTC96 6PK SUCTION/ANTICOAGULATION Medical Device Identification

GUDID 10673978522569

ASSY BTC96 6PK SUCTION/ANTICOAGULATION

MEDTRONIC, INC.

Blood-processing autotransfusion system set

Primary Device ID	10673978522569
NIH Device Record Key	9f4f8128-34fe-4e17-921c-dae50e866e4e
Commercial Distribution Status	In Commercial Distribution
Version Model Number	BTC96
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	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

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00673978522562 [Primary]
GS1	10673978522569 [Package] Contains: 00673978522562 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	2015-06-17

Devices Manufactured by MEDTRONIC, INC.

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20763000651767 - Aortic Punch	2025-03-31 Aortic Punch APU440 - 4.0mm punch size
20763000651774 - Aortic Punch	2025-03-31 Aortic Punch APU444 - 4.4mm punch size