A-V Impulse 5007

GUDID 20884521101453

Tubing Assembly, Unrestricted, Blue

Cardinal Health, Inc.

Multi-chamber venous compression system garment, single-use

• Primary Device ID: 20884521101453
• NIH Device Record Key: 124bec32-62bb-4774-91a9-5c3303bd5229
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A-V Impulse
• Version Model Number: 5007
• Catalog Number: 5007
• Company DUNS: 080935429
• Company Name: Cardinal Health, 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: +1(508)261-8000
• Email: covidien.udi@covidien.com
• Phone: +1(508)261-8000
• Email: covidien.udi@covidien.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *
• Special Storage Condition, Specify: Between 0 and 0 *

Device Identifiers

Device Issuing Agency	Device ID
GS1	20884521101453 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964425

FDA Product Code

• JOW: SLEEVE, LIMB, COMPRESSIBLE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-04-15
• Device Publish Date: 2017-07-11

On-Brand Devices [A-V Impulse]

• 20884521101453: Tubing Assembly, Unrestricted, Blue
• 10884521078123: Impad Rigid Sole Foot Cover, Large
• 10884521078116: Impad Rigid Sole Foot Cover, Medium
• 10884521077386: Impad Rigid Sole Foot Cover, X- Large
• 10884521077379: Impad Rigid Sole Foot Cover, Large
• 10884521077348: Impad Rigid Sole Foot Cover, Medium
• 10884521077300: Impad Rigid Sole Foot Cover;Small
• 10884521100190: 6000 Series Controller,Refurbished
• 10884521100152: 6000 Series Controller
• 20884521077277: Impad Rigid Sole Foot Cover,Left
• 20884521077260: Impad Rigid Sole Foot Cover,Right
• 10884521043923: 6000 Series Controller