Luther Needlesafe Products 18175001

GUDID 10850017259000

Mini-Midline Extended Dwell Peripheral Catheter - 18Ga, 1.75”

Luther Needlesafe Products, LLC

Peripheral intravenous cannula

• Primary Device ID: 10850017259000
• NIH Device Record Key: 8e419380-6c72-4ccd-8673-dd3e22345e91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Luther Needlesafe Products
• Version Model Number: 18175001
• Catalog Number: 18175001
• Company DUNS: 117440613
• Company Name: Luther Needlesafe Products, LLC
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850017259003 [Primary]
GS1	10850017259000 [Package]; Contains: 00850017259003; Package: Inner Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130518

FDA Product Code

• FOZ: Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-09
• Device Publish Date: 2023-05-01

On-Brand Devices [Luther Needlesafe Products]

• 00850017259058: Mini-Midline Extended Dwell Peripheral Catheter - 24Ga, 1.25”
• 10850017259048: Mini-Midline Extended Dwell Peripheral Catheter - 22Ga, 1.75”
• 10850017259031: Mini-Midline Extended Dwell Peripheral Catheter - 22Ga, 1.50”
• 10850017259024: Mini-Midline Extended Dwell Peripheral Catheter - 20Ga, 1.75”
• 10850017259017: Mini-Midline Extended Dwell Peripheral Catheter - 20Ga, 1.50”
• 10850017259000: Mini-Midline Extended Dwell Peripheral Catheter - 18Ga, 1.75”