Peregrine System Infusion Catheter

GUDID 00862468000318

Peregrine System Infusion Catheter, US

ABLATIVE SOLUTIONS, INC.

Peripheral vascular infusion catheter

• Primary Device ID: 00862468000318
• NIH Device Record Key: c98439dc-a45b-42ff-8467-d94426192087
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Peregrine System Infusion Catheter
• Version Model Number: FG32101
• Company DUNS: 078293273
• Company Name: ABLATIVE SOLUTIONS, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com
• Phone: 650-688-9743
• Email: producthandling@ablativesolutions.com

Device Dimensions

• Outer Diameter: 0.078 Inch
• Outer Diameter: 0.078 Inch
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch
• Length: 86 Centimeter
• Device Size Text, specify: 0
• Outer Diameter: 0.078 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00862468000318 [Primary]

FDA Product Code

• KRA: Catheter, Continuous Flush

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: 2017-05-24

Devices Manufactured by ABLATIVE SOLUTIONS, INC.

• 00862468000349 - Peregrine System™ Infusion Catheter: 2024-03-06 Peregrine System™ Infusion Catheter (4-7 mm), 510k, US
• 00862468000356 - Peregrine System™ Infusion Catheter: 2024-03-06 Peregrine System™ Infusion Catheter (3-4 mm), 510k, US
• 00862468000318 - Peregrine System Infusion Catheter: 2019-04-09Peregrine System Infusion Catheter, US
• 00862468000318 - Peregrine System Infusion Catheter: 2019-04-09 Peregrine System Infusion Catheter, US