FreedomEdgeTM F10020

GUDID 00659443000018

Mechanical Syringe Infusion Pump

REPRO MED SYSTEMS, INC.

Elastomeric infusion pump system filling device Elastomeric infusion pump system filling device

• Primary Device ID: 00659443000018
• NIH Device Record Key: 82a71a59-166b-4aab-ac93-cd445d0738e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FreedomEdgeTM
• Version Model Number: F10020
• Catalog Number: F10020
• Company DUNS: 048403299
• Company Name: REPRO MED SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place
• Special Storage Condition, Specify: Between 0 and 0 *Store in a cool, dry place

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659443000018 [Primary]

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-19

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