SynchroMed® II

GUDID 00643169530126

PUMP 8637-40 SYNCHMED II 40ML DLC MOTOR

MEDTRONIC, INC.

Implantable intrathecal infusion pump, programmable Implantable intrathecal infusion pump, programmable
Primary Device ID00643169530126
NIH Device Record Key622e580d-8d40-4f38-a041-8776661880be
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

Device Dimensions

Total Volume40 Milliliter
Total Volume40 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169530126 [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 Number4
Public Version Date2019-08-08
Device Publish Date2017-07-17

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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