BD Insyte-N Autoguard 381811

GUDID 50382903818117

INSYTE-N AUTOGUARD YEL 24GA 0.56IN

BECTON, DICKINSON AND COMPANY

Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula Peripheral intravenous cannula

• Primary Device ID: 50382903818117
• NIH Device Record Key: e64a0ee3-a070-4b13-8887-9ae8c6636014
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte-N Autoguard
• Version Model Number: 381811
• Catalog Number: 381811
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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	00382903818112 [Primary]
GS1	30382903818113 [Package]; Contains: 00382903818112; Package: Shelfpack [200 Units]; In Commercial Distribution
GS1	50382903818117 [Package]; Contains: 30382903818113; Package: Case [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201075

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: 2
• Public Version Date: 2024-02-26
• Device Publish Date: 2022-12-22

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