VASOBand VB-2900-AL

GUDID 00860004749745

The VASOBand is a compression device to assist hemostasis of the radial artery after a transradial procedure.

VASOINNOVATIONS INC.

Radial artery compression device

• Primary Device ID: 00860004749745
• NIH Device Record Key: aa99e03f-fbd6-4307-82c1-25c637a9ca53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VASOBand
• Version Model Number: VB-2900-AL
• Catalog Number: VB-2900-AL
• Company DUNS: 071926350
• Company Name: VASOINNOVATIONS 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: true
• 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: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com
• Phone: (323) 999-7562
• Email: support@vasoinnovations.com

Device Dimensions

• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter
• Circumference: 29 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Avoid exposure to water, direct sunlight, or extreme temperatures or high humidity
• Storage Environment Humidity: Between 5 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 4 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860004749745 [Package]; Contains: 00866691000343; Package: Shelf box [5 Units]; In Commercial Distribution
GS1	00866691000343 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190318

FDA Product Code

• DXC: Clamp, Vascular

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: 2021-01-13
• Device Publish Date: 2021-01-05

On-Brand Devices [VASOBand]

• 00860004749752: The VASOBand is a compression device to assist hemostasis of the radial artery after a transradi
• 00860004749745: The VASOBand is a compression device to assist hemostasis of the radial artery after a transradi
• 00860004749738: The VASOBand is a compression device to assist hemostasis of the radial artery after a transradi
• 00860004749721: The VASOBand is a compression device to assist hemostasis of the radial artery after a transradi
• 00866691000312: The VASOBandTM is a compression device to assist hemostasis of the radial artery after a transra
• 00860004749714: The VASOBand is a compression device to assist hemostasis of the radial artery after a transradi