KORU 348143

GUDID 00659443003132

Freedom60 Prefilled Syringe Adapter

REPRO MED SYSTEMS, INC.

Ambulatory non-insulin infusion pump, mechanical, reusable

• Primary Device ID: 00659443003132
• NIH Device Record Key: 45f52554-c647-4512-a7b7-d8fea5257dc4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KORU
• Version Model Number: 348143
• Catalog Number: 348143
• Company DUNS: 048403299
• Company Name: REPRO MED SYSTEMS, INC.
• 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: false
• Expiration Date: false
• 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: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com
• Phone: +1(800)624-9600
• Email: info@korumedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659443003118 [Primary]
GS1	00659443003132 [Package]; Contains: 00659443003118; Package: Carton [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231918

FDA Product Code

• FRN: Pump, infusion

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-26
• Device Publish Date: 2023-12-18

On-Brand Devices [KORU]

• 00659443003132: Freedom60 Prefilled Syringe Adapter
• 00659443004450: Freedom60 Infusion Pump with Prefilled Syringe Adapter