BD Insyte-N Autoguard 381511

GUDID 50382903815116

INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter

• Primary Device ID: 50382903815116
• NIH Device Record Key: 94998b47-118e-41d6-ae61-14247bc8a255
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte-N Autoguard
• Version Model Number: 381511
• Catalog Number: 381511
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 50
• DM Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903815111 [Unit of Use]
GS1	30382903815112 [Primary]
GS1	50382903815116 [Package]; Contains: 30382903815112; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201075
• Premarket Notification: K952861

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [BD Insyte-N Autoguard]

• 50382903815116: INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
• 50382903814119: INSYTE-N AUTOGUARD YEL 24GA X .56IN
• 50382903819114: INSYTE-N AUTOGUARD WINGED YEL 24GAX.56IN
• 50382903818117: INSYTE-N AUTOGUARD YEL 24GA 0.56IN