FREEDOM60® F10050

GUDID 00659443000001

Mechanical Syringe Infusion Pump

REPRO MED SYSTEMS, INC.

Elastomeric infusion pump system filling device

• Primary Device ID: 00659443000001
• NIH Device Record Key: f3b809fa-d1bc-48f2-ba65-2eeb27710c60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FREEDOM60®
• Version Model Number: F10050
• Catalog Number: F10050
• 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	00659443000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162613

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: 2016-08-19

Devices Manufactured by REPRO MED SYSTEMS, INC.

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• 10659443002835 - HIgH-Flo™ Needle Set: 2019-05-30 26 Gauge Needle Sets 2 leg 4mm
• 10659443002866 - HIgH-Flo™ Needle Set: 2019-05-30 26 Gauge Needle Sets 2 leg 12mm
• 10659443002781 - HIgH-Flo™ Needle Set: 2019-05-24 26 Gauge Needle Sets 1 leg 4mm
• 10659443002798 - HIgH-Flo™ Needle Set: 2019-05-24 26 Gauge Needle Sets 1 leg 6mm
• 10659443002804 - HIgH-Flo™ Needle Set: 2019-05-24 26 Gauge Needle Sets 1 leg 9mm