ACTitouch

GUDID 00816305022940

TACTILE SYSTEMS TECHNOLOGY, INC.

Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00816305022940
• NIH Device Record Key: db953fce-3393-4a9d-a669-c22beb9bdbae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACTitouch
• Version Model Number: DS 500222-000
• Company DUNS: 146295980
• Company Name: TACTILE SYSTEMS TECHNOLOGY, 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305022940 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K071763

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-27

On-Brand Devices [ACTitouch]

• 00816305023367: R 500234-000
• 00816305023350: R 500234-000-00
• 00816305023268: DS 500324-002-00
• 00816305023251: DS 500324-001-00
• 00816305023244: DS 500324-000-00
• 00816305023237: DS 500236-000-00
• 00816305023220: DS 500224-300-00
• 00816305023213: DS 500224-200-00
• 00816305023206: DS 500224-100-00
• 00816305023190: DS 500224-000-00
• 00816305023183: DS 500322-500-00
• 00816305023176: DS 500322-500
• 00816305023169: DS 500322-400-00
• 00816305023152: DS 500322-400
• 00816305023145: DS 500322-300-00
• 00816305023138: DS 500322-300
• 00816305023121: DS 500322-200-00
• 00816305023114: DS 500322-200
• 00816305023107: DS 500322-100-00
• 00816305023091: DS 500322-100
• 00816305023077: DS 500322-000-00
• 00816305023060: DS 500322-000
• 00816305023053: DS 500222-500-00
• 00816305023046: DS 500222-500
• 00816305023039: DS 500222-400-00
• 00816305023022: DS 500222-400
• 00816305023015: DS 500222-300-00
• 00816305023008: DS 500222-300
• 00816305022995: DS 500222-200-00
• 00816305022988: DS 500222-200
• 00816305022971: DS 500222-100-00
• 00816305022964: DS 500222-100
• 00816305022957: DS 500222-000-00
• 00816305022940: DS 500222-000
• 00816305022933: DS 500234-000
• 00816305022926: DS 500234-000-00
• 00816305021431: 500324-002-00
• 00816305021424: 500324-001-00
• 00816305021417: 500324-000-00
• 00816305021134: 500224-300-00
• 00816305021127: 500224-200-00
• 00816305021110: 500224-100-00
• 00816305021103: 500224-000-00
• 00816305020953: 500236-000-00
• 00816305020946: 500322-500-00
• 00816305020939: 500322-500
• 00816305020922: 500322-400-00
• 00816305020915: 500322-400
• 00816305020908: 500322-300-00
• 00816305020892: 500322-300