BD Insyte™ Autoguard™ BC Pro 392554

GUDID 30382903925545

IAG BC PRO GRAY 16GA X 1.16IN

BECTON, DICKINSON AND COMPANY

Peripheral intravenous cannula

• Primary Device ID: 30382903925545
• NIH Device Record Key: fa77c02d-f186-43e0-b549-fbffdad7587a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BD Insyte™ Autoguard™ BC Pro
• Version Model Number: 392554
• Catalog Number: 392554
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature
• Special Storage Condition, Specify: Between 0 and 0 *Room Temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903925544 [Primary]
GS1	30382903925545 [Package]; Contains: 00382903925544; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	50382903925549 [Package]; Contains: 00382903925544; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-10
• Device Publish Date: 2021-09-02

On-Brand Devices [BD Insyte™ Autoguard™ BC Pro]

• 30382903925545: IAG BC PRO GRAY 16GA X 1.16IN
• 50382903925440: IAG BC PRO GRN 18GA X 1.16IN