SYNCHROMED ® II

Basic Information

• Brand Name: SYNCHROMED ® II
• Primary DI: 00613994779229
• Version / Model: 8637-20
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-04-27
• Public Version: 4
• Public Version Date: 2022-12-23
• Public Version Status: Update
• Public Device Record Key: 9698bdb3-661b-4900-919f-2d130abf8d75
• Distribution End Date: 2022-10-25

Device Description

PUMP 8637-20 SM2 20ML EMAN US JUN BATRY

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: Yes
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LKK	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
46024	Implantable intrathecal infusion pump, programmable	A battery-powered, programmable, sterile device designed to be implanted in a patient for the storing and subarachnoid (intrathecal) administration of narcotics/drugs (e.g., morphine sulfate, baclofen) to manage intractable pain and muscle spasms of malignant or non-malignant origin. This implantable infusion pump (IIP) delivers drug doses from its implanted reservoir which is controlled by drug concentration and/or by radio-frequency (RF) signals from an external programming device. The drug reservoir, usually implanted under the skin of the lower abdomen, is typically connected to a catheter placed into the spinal fluid space.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00613994779229	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P860004	130

Device Sizes

Type	Value	Unit	Text
Total Volume	20.0	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from Magnets
• Type: Handling Environment Temperature
• Temperature Range: 41 – 110 Degrees Fahrenheit
• Type: Handling Environment Temperature
• Temperature Range: 5 – 43 Degrees Celsius