Entre Plus 701628-001

GUDID 00816305023756

Port Plug Assembly

Tactile Systems Technology, Inc.

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• Primary Device ID: 00816305023756
• NIH Device Record Key: 807fe5e0-5b78-4635-9926-2876cb514efe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Entre Plus
• Version Model Number: PD08-NG
• Catalog Number: 701628-001
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816305023756 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143185

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: 2023-03-28
• Device Publish Date: 2023-03-20

On-Brand Devices [Entre Plus]

• 00816305023756: Port Plug Assembly
• 00816305023701: Entre Plus Non-VA Controller
• 00816305024524: Non-VA Reconditioned Controller