entre

GUDID 00816305023305

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: 00816305023305
• NIH Device Record Key: 7331de7c-fc91-4404-8be7-8ef2d906e6cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: entre
• Version Model Number: DS 300018-000-00
• 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	00816305023305 [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-05-04
• Device Publish Date: 2017-12-08

On-Brand Devices [entre]

• 00816305023343: R PD08-U
• 00816305023329: DS L-EX-LO-A
• 00816305023312: DS L-EX-SH-A
• 00816305023305: DS 300018-000-00
• 00816305023299: DS 300017-000-00
• 00816305021646: DS L-HL-00-A
• 00816305021639: DS L-FL-LO-A
• 00816305021622: DS L-FL-SH-A
• 00816305021615: DS U-AR-LO-A
• 00816305021608: DS U-AR-SH-A
• 00816305020090: 300018-000-00
• 00816305020083: 300017-000-00
• 00816305020076: L-EX-LO-A
• 00816305020069: L-EX-SH-A
• 00816305020052: L-FL-LO-A
• 00816305020045: L-FL-SH-A
• 00816305020038: L-HL-00-A
• 00816305020021: U-AR-LO-A
• 00816305020014: U-AR-SH-A
• 00816305020007: PD08-U