PulseSpray

GUDID H787125004075

PulseSpray Infusion System

ANGIODYNAMICS, INC.

Peripheral vascular infusion catheter

• Primary Device ID: H787125004075
• NIH Device Record Key: 2956c703-4b5f-4242-bb7b-49e7b5a49944
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PulseSpray
• Version Model Number: 12500407
• Company DUNS: 079105071
• Company Name: ANGIODYNAMICS, 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com
• Phone: +1(518)795-1676
• Email: dgreer@angiodynamics.com

Device Dimensions

• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French
• Length: 90 Centimeter
• Catheter Gauge: 5 French

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius
• Storage Environment Temperature: Between 0 and 27 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	15051684013130 [Secondary]
HIBCC	H787125004070 [Primary]
HIBCC	H787125004075 [Package]; Contains: H787125004070; Package: BOX [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163356

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: 5
• Public Version Date: 2020-01-13
• Device Publish Date: 2016-09-19

On-Brand Devices [PulseSpray]

• H787525030025: PulseSpray Infusion System
• H787125004655: PulseSpray Infusion System
• H787125004645: PulseSpray Infusion System
• H787125004635: PulseSpray Infusion System
• H787125004625: PulseSpray Infusion System
• H787125004615: PulseSpray Infusion System
• H787125004595: PulseSpray Infusion System
• H787125004585: PulseSpray Infusion System
• H787125004575: PulseSpray Infusion System
• H787125004565: PulseSpray Infusion System
• H787125004555: PulseSpray Infusion System
• H787125004545: PulseSpray Infusion System
• H787125004535: PulseSpray Infusion System
• H787125004525: PulseSpray Infusion System
• H787125004515: PulseSpray Infusion System
• H787125004505: PulseSpray Infusion System
• H787125004495: PulseSpray Infusion System
• H787125004485: PulseSpray Infusion System
• H787125004475: PulseSpray Infusion System
• H787125004465: PulseSpray Infusion System
• H787125004455: PulseSpray Infusion System
• H787125004445: PulseSpray Infusion System
• H787125004435: PulseSpray Infusion System
• H787125004425: PulseSpray Infusion System
• H787125004415: PulseSpray Infusion System
• H787125004405: PulseSpray Infusion System
• H787125004395: PulseSpray Infusion System
• H787125004385: PulseSpray Infusion System
• H787125004375: PulseSpray Infusion System
• H787125004365: PulseSpray Infusion System
• H787125004355: PulseSpray Infusion System
• H787125004345: PulseSpray Infusion System
• H787125004335: PulseSpray Infusion System
• H787125004325: PulseSpray Infusion System
• H787125004315: PulseSpray Infusion System
• H787125004305: PulseSpray Infusion System
• H787125004295: PulseSpray Infusion System
• H787125004285: PulseSpray Infusion System
• H787125004275: PulseSpray Infusion System
• H787125004265: PulseSpray Infusion System
• H787125004255: PulseSpray Infusion System
• H787125004245: PulseSpray Infusion System
• H787125004235: PulseSpray Infusion System
• H787125004225: PulseSpray Infusion System
• H787125004215: PulseSpray Infusion System
• H787125004205: PulseSpray Infusion System
• H787125004195: PulseSpray Infusion System
• H787125004185: PulseSpray Infusion System
• H787125004175: PulseSpray Infusion System
• H787125004165: PulseSpray Infusion System