SYNCHROMED®II

GUDID 00643169984219

PUMP 8637-20 SYNCHROMED II 20ML DLC US

MEDTRONIC, INC.

Implantable intrathecal infusion pump, programmable
Primary Device ID00643169984219
NIH Device Record Keyb6b39591-2e8c-4e69-9335-b4eb318a6eaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSYNCHROMED®II
Version Model Number8637-20
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

Device Dimensions

Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from magnets
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169984219 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-08
Device Publish Date2018-07-09

On-Brand Devices [SYNCHROMED®II]

00643169984226PUMP 8637-40 SYNCHROMED II 40ML DLC US
00643169984219PUMP 8637-20 SYNCHROMED II 20ML DLC US
00763000422615PUMP 8637-40 SM II 40ML EMAN SYMBL GRC
00763000422608PUMP 8637-20 SM II 20ML EMAN SYMBL GRC

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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