Medisystems OneSite dual lumen needle with masterguard

GUDID 10842289100784

MEDISYSTEMS CORPORATION

Haemodialysis needle

• Primary Device ID: 10842289100784
• NIH Device Record Key: d24358e8-75d1-405d-8b05-a6d50ae2790d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Medisystems OneSite dual lumen needle with masterguard
• Version Model Number: DL-2014MGE
• Company DUNS: 061310132
• Company Name: MEDISYSTEMS CORPORATION
• 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: 1-866-697-8243
• Email: info@nxstage.com

Device Dimensions

• Needle Gauge: 14 Gauge
• Needle Gauge: 14 Gauge

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00842289100787 [Primary]
GS1	10842289100784 [Package]; Contains: 00842289100787; Package: [150 Units]; In Commercial Distribution

FDA Product Code

• FIE: Needle, Fistula

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-16

On-Brand Devices [Medisystems OneSite dual lumen needle with masterguard]

• 10842289100784: DL-2014MGE
• 10842289100760: DL-2004MGE
• 10842289100746: DL-1214MGE
• 10842289100722: DL-1204MGE