TwoFer Needle 16004

GUDID 00085412478395

TwoFer Huber-Tipped Needle

MEDSAFETY SOLUTIONS LLC

Medication transfer needle, non-filtering/non-vented

• Primary Device ID: 00085412478395
• NIH Device Record Key: acc45930-e7e6-4375-bfaf-0ac14075154c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TwoFer Needle
• Version Model Number: 16004
• Catalog Number: 16004
• Company DUNS: 080521478
• Company Name: MEDSAFETY SOLUTIONS 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: false
• Expiration Date: true
• 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: 1-720-500-2500
• Email: info@medsafetysolutions.com

Device Dimensions

• Needle Gauge: 16 Gauge

Device Identifiers

Device Issuing Agency	Device ID
GS1	00085412478395 [Previous]
GS1	00853832007071 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K832347

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-08-09
• Device Publish Date: 2017-12-01

On-Brand Devices [TwoFer Needle]

• 00085412478395: TwoFer Huber-Tipped Needle
• 00085412478418: TwoFer Huber-Tipped Needle