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Care Touch

FDA UDI

Class II (US FDA UDI)

by Future Diagnostics Llc

Identity

Trade Name
Care Touch FDA UDI
Generic Name
Patient monitoring system module, blood pressure, noninvasive FDA UDI
Device Name
Digital Wrist Blood Pressure Monitor FDA UDI
Model / Reference
CTCSW FDA UDI
Description
Digital Wrist Blood Pressure Monitor FDA UDI

Identifiers

Primary DI / UDI-DI
00370393904019 FDA UDI
510(k) Number
K131463 FDA UDI
FDA Product Code
DXN FDA UDI
GMDN Term
Patient monitoring system module, blood pressure, noninvasive FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1130 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Patient monitoring system module, blood pressure, noninvasive

Care Touch by Future Diagnostics Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Patient monitoring system module, blood pressure, noninvasive.

Cleared under the same submission

K131463 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Future Diagnostics Llc

Sources (1)

  • FDA UDI 86e3fd62-f3e2-4586-bb6b-7da4fdb8be73 35 fields · synced May 30, 2026