GUDID 20613994842934

RESERVOIR EL402 4L 20MICR CARDIOTOMY 6PK

MEDTRONIC, INC.

Cardiotomy reservoir
Primary Device ID20613994842934
NIH Device Record Keye671f3d0-e9e9-441a-9348-b34a90d73440
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberEL402
Company DUNS006261481
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Device Dimensions

Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer
Pore Size20 Micrometer

Operating and Storage Conditions

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994842930 [Primary]
GS120613994842934 [Package]
Contains: 00613994842930
Package: PK [6 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTNRESERVOIR, BLOOD, CARDIOPULMONARY BYPASS

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-01-22
Device Publish Date2016-07-23

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