SYNCHROMED ® II

GUDID 00613994779229

PUMP 8637-20 SM2 20ML EMAN US JUN BATRY

MEDTRONIC, INC.

General-purpose implantable infusion pump, programmable General-purpose implantable infusion pump, programmable
Primary Device ID00613994779229
NIH Device Record Key9698bdb3-661b-4900-919f-2d130abf8d75
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 StatusLabeling does not contain MRI Safety Information
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 Volume20 Milliliter
Total Volume20 Milliliter

Operating and Storage Conditions

Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit
Handling Environment TemperatureBetween 41 Degrees Fahrenheit and 110 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100613994779229 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-04-27

On-Brand Devices [SYNCHROMED ® II]

00613994779229PUMP 8637-20 SM2 20ML EMAN US JUN BATRY
00643169100831PUMP 8637-20 SYNCHMED II 20ML PF
00643169100824PUMP 8637-40 SYNCHMED II 40ML PF

Trademark Results [SYNCHROMED]

Mark Image

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.