DVT DVT55002

GUDID 05690977400863

REPLACEMENT CHARGER KIT

OSSUR AMERICAS, INC.

Intermittent venous compression system

• Primary Device ID: 05690977400863
• NIH Device Record Key: 26b2810b-7439-4176-95a3-80e7ef6e8bd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DVT
• Version Model Number: DVT55002
• Catalog Number: DVT55002
• Company DUNS: 139280028
• Company Name: OSSUR AMERICAS, 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05690977400863 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130174

FDA Product Code

• JOW: SLEEVE, LIMB, COMPRESSIBLE

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-16

On-Brand Devices [DVT]

• 05690977445260: CA5 SMALL CUFF-MEDLINE
• 05690977445253: CA5 X-LARGE CUFF-MEDLINE
• 05690977445246: CA5 LARGE CUFF-MEDLINE
• 05690977445239: HOME PUMP-MEDLINE WH CA5 PUMP
• 05690977400863: REPLACEMENT CHARGER KIT
• 05690977382848: DVT HOME KIT SAMPLE
• 05690977371903: DVT CUFF SMALL
• 05690977371897: DVT CUFF X-LARGE
• 05690977371866: DVT CUFF LARGE
• 05690977369344: POWER SUPPLY - MEDICAL
• 05690977369283: Black CA5 Pump
• 05690977369269: WHITE CA5 PUMP
• 05690977352957: DVT Home Kit