Entre3-LE

GUDID 00816305021011

TACTILE SYSTEMS TECHNOLOGY, INC.

Multi-chamber venous compression system garment, reusable

• Primary Device ID: 00816305021011
• NIH Device Record Key: 5f2eeb88-35cb-4650-bff5-e577ff4ee004
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entre3-LE
• Version Model Number: 0P9BLYM003-ET
• 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	00816305021011 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103247

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: 2016-09-20

On-Brand Devices [Entre3-LE]

• 00816305023374: R 0P9PTVSCP4-03LE
• 00816305021080: 0P9K4PTPLG
• 00816305021073: 0P9BLYM011T
• 00816305021066: 0P9BLYM010T
• 00816305021059: 0P9BLYM009T
• 00816305021042: 0P9BLYM005T
• 00816305021035: 0P9BLYM004T
• 00816305021028: 0P9BLYM003T
• 00816305021011: 0P9BLYM003-ET
• 00816305021004: 0P9BLYM002T
• 00816305020991: 0P9BLYM002-ET
• 00816305020984: 0P9BLYM001T
• 00816305020977: 0P9BLYM001-ET
• 00816305020960: 0P9PTVSCP4-03LE