HIgH-Flo™ Needle Set SUPER12604

GUDID 10659443002781

26 Gauge Needle Sets 1 leg 4mm

REPRO MED SYSTEMS, INC.

Subcutaneous injection/infusion port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle Subcutaneous infusion/injection port needle

• Primary Device ID: 10659443002781
• NIH Device Record Key: c9fe7df7-4f67-4f0b-959c-b03083504e70
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HIgH-Flo™ Needle Set
• Version Model Number: SUPER12604
• Catalog Number: SUPER12604
• 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: true
• 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)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com
• Phone: +1(845)610-5560
• Email: asmith@rmsmedpro.com

Device Dimensions

• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge
• Needle Gauge: 26 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00659443002784 [Primary]
GS1	10659443002781 [Package]; Contains: 00659443002784; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180843

FDA Product Code

• FPA: Set, administration, intravascular

Sterilization

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

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

[10659443002781]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-24
• Device Publish Date: 2019-05-16

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