Insyte Autoguard BC Pro 392524

GUDID 50382903925242

IAGBC PRO BLU 22GA X 1.25IN

BECTON, DICKINSON AND COMPANY

Peripheral intravenous cannula

• Primary Device ID: 50382903925242
• NIH Device Record Key: 79aa88f7-f998-4f40-ac02-4474b10a5e50
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Insyte Autoguard BC Pro
• Version Model Number: 392524
• Catalog Number: 392524
• 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Length: 1.25 Inch

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
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Fragile, handle with care
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry

Device Identifiers

Device Issuing Agency	Device ID
GS1	00382903925247 [Primary]
GS1	30382903925248 [Package]; Contains: 00382903925247; Package: Shelfpack [50 Units]; In Commercial Distribution
GS1	50382903925242 [Package]; Contains: 30382903925248; 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 [Insyte Autoguard BC Pro]

• 50382903925341: IAG BC PRO PNK 20GA X 1.16IN
• 50382903925334: IAG BC PRO PNK 20GA X 1.0IN
• 50382903925242: IAGBC PRO BLU 22GA X 1.25IN
• 30382903925231: IAG BC PRO BLU 22GA X 1.0IN
• 30382903926542: IAG BC PRO WING GRAY 16GA X 1.16IN
• 30382903926474: IAG BC PRO WING GRN 18GAX1.88IN
• 50382903926447: IAG BC PRO WING GRN 18GAX1.16IN
• 50382903926379: IAG BC PRO WING PNK 20GA X1.88IN
• 30382903926344: IAG BC PRO WING PNK 20GA X1.16IN
• 50382903926331: IAG BC PRO WING PNK 20GA X 1.0IN
• 50382903926232: IAG BC PRO WING BLU 22GA X 1.0IN
• 50382903926126: IAG BC PRO WING YEL 24GA X .75IN
• 50382903925570: IAG BC PRO GRAY 16GA X 1.77IN
• 30382903925378: IAG BC PRO PNK 20GA X 1.88IN
• 50382903926577: IAG BC PRO WING GRAY 16GA X 1.77IN
• 50382903926249: IAG BC PRO WING BLU 22GA X 1.25IN
• 30382903925125: IAG BC PRO YEL 24GA X .75IN
• 50382903925471: IAG BC PRO GRN 18GA X 1.88IN