SYNCHROMED® II

GUDID 00763000634100

PUMP 8637-40 SM II 40ML EMAN SYMBL

MEDTRONIC, INC.

Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable
Primary Device ID00763000634100
NIH Device Record Key8f960388-970f-4e11-9766-67176480dfe5
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHROMED® II
Version Model Number8637-40
Company DUNS796986144
Company NameMEDTRONIC, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Producttrue
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
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
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

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Operating and Storage Conditions

Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Handling Environment TemperatureBetween 5 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 131 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Do not freeze
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000634100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LKKPump, infusion, implanted, programmable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-19
Device Publish Date2022-08-11

On-Brand Devices [SYNCHROMED® II]

00643169630512PUMP 8637-40 SYNCHMED II 40ML EMAN SYMBL
00643169630505PUMP 8637-20 SYNCHMED II 20ML EMAN SYMBL
00643169530126PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR
00643169530119PUMP 8637-20 SYNCHMED II 20ML DLC MOTOR
00643169508156PUMP 8637-40 SYNCHMED II 40ML POTTED FTS
00643169508149PUMP 8637-20 SYNCHMED II 20ML POTTED FTS
00763000634100PUMP 8637-40 SM II 40ML EMAN SYMBL
00763000634094PUMP 8637-20 SM II 20ML EMAN SYMBL

Trademark Results [SYNCHROMED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SYNCHROMED
SYNCHROMED
73726779 1551794 Live/Registered
MEDTRONIC, INC.
1988-05-06

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