FlexiTouch Plus N/A

GUDID 00816305025088

FlexiTouch travel bag

Tactile Systems Technology, Inc.

Intermittent venous compression system pump

• Primary Device ID: 00816305025088
• NIH Device Record Key: f055b9a9-a592-4d47-aab9-17facb18fcd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexiTouch Plus
• Version Model Number: 704705-001
• Catalog Number: N/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: false
• 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: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305025088 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203178

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: 1
• Public Version Date: 2025-08-19
• Device Publish Date: 2025-08-11

On-Brand Devices [FlexiTouch Plus]

• 00816305023572: DS 300007-000-00
• 00816305023565: DS 300002-002-00
• 00816305023558: 300002-002-00
• 00816305023541: 300007-000-00
• 00816305023534: DS 500314-300-00
• 00816305023527: DS 500313-300-00
• 00816305023510: DS 500312-300-00
• 00816305023503: DS 500311-300-00
• 00816305023497: DS 500310-300-00
• 00816305023480: DS 500309-300-00
• 00816305023473: DS 500308-300-00
• 00816305023466: 500314-300-00
• 00816305023459: 500313-300-00
• 00816305023442: 500312-300-00
• 00816305023435: 500311-300-00
• 00816305023428: 500310-300-00
• 00816305023411: 500309-300-00
• 00816305023404: 500308-300-00
• 00816305023398: DS 3WX-R
• 00816305023381: R PD32-G3
• 00816305022896: DS 300050-000-00
• 00816305022889: 300045-500-00
• 00816305022872: DS 300002-402-00
• 00816305022858: DS 3U-AS-L2-R
• 00816305022841: 300002-402-00
• 00816305022834: DS 3WX-L
• 00816305022827: DS 3L-HL-XT-R
• 00816305022810: DS 3L-HL-XT-L
• 00816305022803: DS 3L-TR-XT-R
• 00816305022797: DS 3L-TR-XT-L
• 00816305022780: DS 3A-CH-LG-A
• 00816305022773: DS 3A-CH-MD-A
• 00816305022766: DS 3A-CH-SM-A
• 00816305022759: DS 3A-HD-LG-A
• 00816305022742: DS 3A-HD-MD-A
• 00816305022735: DS 3A-HD-SM-A
• 00816305022728: DS 3U-AS-L4-R
• 00816305022711: DS 3U-AS-L4-L
• 00816305022704: DS 3U-AS-S4-R
• 00816305022698: DS 3U-AS-S4-L
• 00816305022681: DS 3U-AS-L3-R
• 00816305022674: DS 3U-AS-L3-L
• 00816305022667: DS 3U-AS-S3-R
• 00816305022650: DS 3U-AS-S3-L
• 00816305022636: DS 3U-AS-L2-L
• 00816305022629: DS 3U-AS-S2-R
• 00816305022612: DS 3U-AS-S2-L
• 00816305022605: DS 3U-AS-L1-R
• 00816305022599: DS 3U-AS-L1-L
• 00816305022582: DS 3U-AS-S1-R