HIgH-Flo™ LRVY

GUDID 10659443000688

Low Residual Volume Y-Connector

REPRO MED SYSTEMS, INC.

Mechanical infusion pump administration set

• Primary Device ID: 10659443000688
• NIH Device Record Key: 0059bda9-c513-4933-b8ec-1f790d9bd899
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIgH-Flo™
• Version Model Number: LRVY
• Catalog Number: LRVY
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com
• Phone: +1(845)610-5587
• Email: fma@rmsmedpro.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659443000681 [Primary]
GS1	10659443000688 [Package]; Contains: 00659443000681; Package: Carton [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K933652

FDA Product Code

• FRN: Pump, infusion

Sterilization

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

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

[10659443000688]

Radiation Sterilization

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

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• 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