Identity
- Trade Name
- Genesis Touch Tab A 8.4 - RCT FDA UDI
- Generic Name
- Home healthcare information system FDA UDI
- Model / Reference
- 6055526B1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817644020161 FDA UDI
- FDA Product Code
- OUG FDA UDI
- GMDN Term
- Home healthcare information system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.6310 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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Home healthcare information system
Genesis Touch Tab A 8.4 - RCT by Mobilehelp Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Home healthcare information system.
- CGMS® Solutions™ — MEDTRONIC MINIMED, INC. · Class III
- Healthcare Access Terminal — BL HEALTHCARE, INC. · Class II
- Genesis Touch Tab E 32 GB — MOBILEHELP LLC · Class II
- Genesis Touch TAB E ATT — MOBILEHELP LLC · Class II
- Genesis DM w ST NIBP 1 — MOBILEHELP LLC · Class II
- Genesis Touch Tab A — MOBILEHELP LLC · Class II
- Genesis DM w OM NIBP — MOBILEHELP LLC · Class II
- Genesis Touch Tab A 8.4 — MOBILEHELP LLC · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Mobilehelp Llc
Sources (1)
- FDA UDI b099ce2c-833b-45c2-bdb9-a250cd9dac98 32 fields · synced May 30, 2026