BD Insyte Autoguard Shielded IV Catheter 381844

GUDID 30382903818441

INSYTE AUTOGUARD GN 18GA X 1.16IN

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter Peripheral vascular catheter 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: 30382903818441
• NIH Device Record Key: 02c7c109-f15d-40e8-b954-79b83837b69a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte Autoguard Shielded IV Catheter
• Version Model Number: 381844
• Catalog Number: 381844
• Company DUNS: 124987988
• Company Name: BECTON, DICKINSON AND COMPANY
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903818440 [Primary]
GS1	30382903818441 [Package]; Contains: 00382903818440; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	50382903818445 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-10-22

On-Brand Devices [BD Insyte Autoguard Shielded IV Catheter]

• 30382903818441: INSYTE AUTOGUARD GN 18GA X 1.16IN
• 30382903818342: INSYTE AUTOGUARD PNK 20GA X 1.16IN
• 30382903818236: INSYTE AUTOGUARD BL 22GA X 1.0IN
• 30382903818120: INSYTE AUTOGUARD YEL 24GA X .75IN