Identity
- Trade Name
- Entre Plus FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- Entre Plus Non-VA Controller FDA UDI
- Model / Reference
- PD08-NG FDA UDI
- Description
- Entre Plus Non-VA Controller FDA UDI
Identifiers
- Catalog Number
- 702854-001 FDA UDI
- Primary DI / UDI-DI
- 00816305023701 FDA UDI
- 510(k) Number
- K143185 FDA UDI
- FDA Product Code
- JOW FDA UDI
- GMDN Term
- Multi-chamber venous compression system garment, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multi-chamber venous compression system garment, reusable
Entre Plus by Tactile Systems Technology Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143185 also covers:
- Entre — TACTILE SYSTEMS TECHNOLOGY INC
- Entre — TACTILE SYSTEMS TECHNOLOGY INC
- Entre Plus — TACTILE SYSTEMS TECHNOLOGY INC
- Entre Plus — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
- entre — TACTILE SYSTEMS TECHNOLOGY INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tactile Systems Technology Inc
Sources (1)
- FDA UDI 50150a43-9de0-4768-8be4-35aaf72daf87 35 fields · synced Jun 8, 2026