Flexitouch

GUDID 00816305022902

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

• Primary Device ID: 00816305022902
• NIH Device Record Key: 60f8a182-37c8-4a7c-9b17-0aa93fcf863d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flexitouch
• Version Model Number: DS 3TX-A
• 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	00816305022902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170216

FDA Product Code

• PPS: Sleeve, Head And Neck, 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: 2017-10-31

On-Brand Devices [Flexitouch]

• 00816305023336: R PD32-U
• 00816305023282: DS WX-R
• 00816305023275: DS WX-L
• 00816305022919: 3TX-A
• 00816305022902: DS 3TX-A
• 00816305022032: DS U-AS-S4-R
• 00816305022025: DS U-AS-S4-L
• 00816305022018: DS U-AS-S3-R
• 00816305022001: DS U-AS-S3-L
• 00816305021998: DS U-AS-S2-R
• 00816305021981: DS U-AS-S2-L
• 00816305021974: DS U-AS-S1-R
• 00816305021967: DS U-AS-S1-L
• 00816305021950: DS U-AS-L4-R
• 00816305021943: DS U-AS-L4-L
• 00816305021936: DS U-AS-L3-R
• 00816305021929: DS U-AS-L3-L
• 00816305021912: DS U-AS-L2-R
• 00816305021905: DS U-AS-L2-L
• 00816305021899: DS U-AS-L1-R
• 00816305021882: DS U-AS-L1-L
• 00816305021875: DS A-CH-SM -A
• 00816305021868: DS A-CH-LG -A
• 00816305021851: DS A-HD-LG-A
• 00816305021844: DS L-TR-XT-R
• 00816305021837: DS L-TR-XT-L
• 00816305021820: DS L-TR-SH-R
• 00816305021813: DS L-TR-SH-L
• 00816305021806: DS L-TR-LO-R
• 00816305021790: DS L-TR-LO-L
• 00816305021783: DS L-FL-SP-R
• 00816305021776: DS L-FL-SP-L
• 00816305021769: DS L-FL-SH-R
• 00816305021752: DS L-FL-SH-L
• 00816305021745: DS L-FL-MD-R
• 00816305021738: DS L -FL-MD-L
• 00816305021721: DS L-FL-LO-R
• 00816305021714: DS L-FL-LO-L
• 00816305021707: DS L-CF-XT-R
• 00816305021691: DS L-CF-XT-L
• 00816305021684: DS L-CF-RG-R
• 00816305021677: DS L-CF-RG-L
• 00816305021660: DS A-TR-SM-A
• 00816305021653: DS A-TR-00-A
• 00816305021592: DS A-CH-MD-A
• 00816305021585: DS A-HD-MD-A
• 00816305021578: DS U-TR-00-R
• 00816305021561: DS U-TR-00-L
• 00816305021554: DS U-CH-S4-R
• 00816305021547: DS U-CH-S4-L