BD Insyte Autoguard Shielded IV Catheter 381834

GUDID 30382903818342

INSYTE AUTOGUARD PNK 20GA X 1.16IN

BECTON, DICKINSON AND COMPANY

Peripheral vascular catheter

• Primary Device ID: 30382903818342
• NIH Device Record Key: cac4399d-f1d3-41b8-9d0e-41229a1aebce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte Autoguard Shielded IV Catheter
• Version Model Number: 381834
• Catalog Number: 381834
• 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	00382903818341 [Primary]
GS1	30382903818342 [Package]; Contains: 00382903818341; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	50382903818346 [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