SCIg60 Infusino System FP-0010002

GUDID 00817708020274

Subcutaneous Immunoglobulin Infusion system

EMED TECHNOLOGIES CORPORATION

General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable General-purpose infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable Ambulatory non-insulin infusion pump, mechanical, reusable

• Primary Device ID: 00817708020274
• NIH Device Record Key: 364e8ce6-8ce6-4f64-b5d8-6a56fb2f523d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCIg60 Infusino System
• Version Model Number: SCIg60 Infuser
• Catalog Number: FP-0010002
• Company DUNS: 622637544
• Company Name: EMED TECHNOLOGIES CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com
• Phone: (916) 932-0071
• Email: customerservice@emedtc.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between -5 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817708020274 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142319

FDA Product Code

• PKP: Immunoglobulin G (Igg) Infusion System

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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