RESERVOIR EL240 4L 40MICR CARDIOTOMY 6PK Medical Device Identification

GUDID 20613994842910

RESERVOIR EL240 4L 40MICR CARDIOTOMY 6PK

MEDTRONIC, INC.

Blood-processing autotransfusion system set

Primary Device ID	20613994842910
NIH Device Record Key	480513b5-e881-4cac-a62c-099d174aefe7
Commercial Distribution Status	In Commercial Distribution
Version Model Number	EL240
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

Device Dimensions

Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer
Pore Size	40 Micrometer

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
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00613994842916 [Primary]
GS1	20613994842910 [Package] Contains: 00613994842916 Package: PK [6 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K930154

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	3
Public Version Date	2018-07-06
Device Publish Date	2015-06-18

Devices Manufactured by MEDTRONIC, INC.

00199150026654 - NA	2025-07-07 CUSTOM PACK BB11E82R2 CB E SUPP
00199150026661 - NA	2025-07-07 CUSTOM PACK BB7D23R7 RADL
00199150026722 - NA	2025-07-07 CUSTOM PACK BB8T30R14 3/8 COMER
00199150026739 - NA	2025-07-07 CUSTOM PACK BB12B00R3 3/8 SUPPORT
20199150026887 - NA	2025-07-07 CUSTOM PACK BB8M18R1 2PK 1/4 LINES
00199150026890 - NA	2025-07-07 CUSTOM PACK BB6U14R7 TABLE PK
00199150026906 - NA	2025-07-07 CUSTOM PACK BB11S65R3 UAB L U N G T
20199150026924 - NA	2025-07-07 CUSTOM PACK BB11F17R2 5PK PERF DISTAL P