SYNCHROMED®II

Basic Information

• Brand Name: SYNCHROMED®II
• Primary DI: 00763000422615
• Version / Model: 8637-40
• Company Name: MEDTRONIC, INC.
• Labeler DUNS: 796986144
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-11
• Public Version: 1
• Public Version Date: 2021-04-19
• Public Version Status: New
• Public Device Record Key: de5db3dc-c9ae-4f86-9ac3-fc15819e60d4

Device Description

PUMP 8637-40 SM II 40ML EMAN SYMBL GRC

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: MR Conditional
• 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	00763000422615	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P860004	369

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: 5 – 55 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Do not freeze
• Type: Handling Environment Temperature
• Temperature Range: 41 – 131 Degrees Fahrenheit
• Type: Storage Environment Temperature
• Temperature Range: 59 – 86 Degrees Fahrenheit
• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from magnets
• Type: Storage Environment Temperature
• Temperature Range: 15 – 30 Degrees Celsius