RESERVOIR EL402 4L 20MICR CARDIOTOMY 6PK Medical Device Identification

GUDID 20613994842934

RESERVOIR EL402 4L 20MICR CARDIOTOMY 6PK

MEDTRONIC, INC.

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Primary Device ID	20613994842934
NIH Device Record Key	e671f3d0-e9e9-441a-9348-b34a90d73440
Commercial Distribution Status	In Commercial Distribution
Version Model Number	EL402
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
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

Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer
Pore Size	20 Micrometer

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.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994842930 [Primary]
GS1	20613994842934 [Package] Contains: 00613994842930 Package: PK [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K926250

FDA Product Code

DTN	RESERVOIR, BLOOD, 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	5
Public Version Date	2020-01-22
Device Publish Date	2016-07-23

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