← Back to catalogue

Genesis Touch TAB E

FDA UDI

Class II (US FDA UDI)

by Mobilehelp Llc

Identity

Trade Name
Genesis Touch TAB E FDA UDI
Generic Name
Home healthcare information system FDA UDI
Model / Reference
6055223B1 FDA UDI

Identifiers

Primary DI / UDI-DI
00817644020017 FDA UDI
510(k) Number
K112858 FDA UDI
FDA Product Code
DRG FDA UDI
GMDN Term
Home healthcare information 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: Home healthcare information system

Genesis Touch TAB E by Mobilehelp Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Home healthcare information system.

Cleared under the same submission

K112858 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Mobilehelp Llc

Sources (1)

  • FDA UDI 97f3785f-f6b1-4274-b2e1-f0ad8f5a1eba 33 fields · synced May 31, 2026