Identity
- Trade Name
- Nimbl FDA UDI
- Generic Name
- Multi-chamber venous compression system garment, reusable FDA UDI
- Device Name
- Bilateral Adapter, Short FDA UDI
- Model / Reference
- 704515-001 FDA UDI
- Description
- Bilateral Adapter, Short FDA UDI
Identifiers
- Catalog Number
- N/A FDA UDI
- Primary DI / UDI-DI
- 00816305024944 FDA UDI
- 510(k) Number
- K234155 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
Yes
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
Nimbl 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
K234155 also covers:
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — TACTILE SYSTEMS TECHNOLOGY INC
- Nimbl — 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 0b61a2f6-2303-41dc-83d5-2703cbee8ae0 36 fields · synced Jun 8, 2026