Identity
- Trade Name
- InTouch Health FDA UDI
- Generic Name
- Diagnostic imaging telemedicine system FDA UDI
- Model / Reference
- Lite Remote Presence System V3 FDA UDI
Identifiers
- Catalog Number
- 20-13333 FDA UDI
- Primary DI / UDI-DI
- 00868772000143 FDA UDI
- 510(k) Number
- K120895 FDA UDI
- FDA Product Code
- DRG FDA UDI
- GMDN Term
- Diagnostic imaging telemedicine system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2910 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
No
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: Diagnostic imaging telemedicine system
InTouch Health by Intouch Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Diagnostic imaging telemedicine system.
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- ENDOPRO IQ — PENTAX of America, Inc. · Class II
- InTouch Health — Intouch Technologies · Class II
- InTouch Health — Intouch Technologies · Class II
- InTouch Health — Intouch Technologies · Class II
- InTouch Health — Intouch Technologies · Class II
Cleared under the same submission
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
- Intouch Technologies
Sources (1)
- FDA UDI f80bfff3-c767-42f6-b4c9-d5f29035ecd9 34 fields · synced May 30, 2026