SCIg60 Infusion System

Basic Information

• Brand Name: SCIg60 Infusion System
• Primary DI: 00817708020274
• Version / Model: FP-0010002
• Catalog Number: FP-0010002
• Company Name: EMED TECHNOLOGIES CORPORATION
• Labeler DUNS: 622637544
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 8
• Public Version Date: 2023-08-07
• Public Version Status: Update
• Public Device Record Key: 364e8ce6-8ce6-4f64-b5d8-6a56fb2f523d

Device Description

SCIg60 Infuser (Mechanical Pump) Assembly

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PKP	Immunoglobulin G (Igg) Infusion System	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46845	Ambulatory non-insulin infusion pump, mechanical, reusable	A non-electric, mechanically-powered (e.g., a spring mechanism) device designed for the continuous or intermittent infusion of medication, typically for antibiotic therapy, chemotherapy, or patient-controlled analgesia (PCA) by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It is primarily designed to be worn by the patient during ambulation in the home. It may include flow and fluid level mechanical indicators and may be worn by the patient within and outside healthcare settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817708020274	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K142319	000
K161906	000
K173783	000
K222087	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -5 – 40 Degrees Celsius