PRESSANA

GUDID 14960685205028

TORAY INDUSTRIES,INC.

Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter Peripheral vascular intervention infusion catheter

• Primary Device ID: 14960685205028
• NIH Device Record Key: da3d9ab1-84dd-40f1-96ae-8b277aae628e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PRESSANA
• Version Model Number: OPC-0308135
• Company DUNS: 690535422
• Company Name: TORAY INDUSTRIES,INC.
• 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

Customer Support Contacts

• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx
• Phone: 2815872299
• Email: xx@xx.xx

Device Dimensions

• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French
• Device Size Text, specify: 0
• Length: 135 Centimeter
• Catheter Gauge: 6 French

Device Identifiers

Device Issuing Agency	Device ID
GS1	04960685205021 [Primary]
GS1	14960685205028 [Package]; Contains: 04960685205021; Package: [1 Units]; In Commercial Distribution

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-04-09
• Device Publish Date: 2017-03-22

On-Brand Devices [PRESSANA]

• 14960685205424: OPC-0708135
• 14960685205035: OPC-0315135
• 14960685205028: OPC-0308135