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Intesys Clinical Suite

FDA UDI

Class II (US FDA UDI)

by Spacelabs Healthcare (washington), Inc

Identity

Trade Name
Intesys Clinical Suite FDA UDI
Generic Name
Medical equipment clinical data interfacing software FDA UDI
Device Name
CUSTOM TRENDS,92876 FDA UDI
Model / Reference
Smart Disclosure FDA UDI
Description
CUSTOM TRENDS,92876 FDA UDI

Identifiers

Catalog Number
92876 FDA UDI
Primary DI / UDI-DI
10841522123597 FDA UDI
510(k) Number
K110779 FDA UDI
FDA Product Code
DQK FDA UDI
GMDN Term
Medical equipment clinical data interfacing software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.1425 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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Medical equipment clinical data interfacing software

Intesys Clinical Suite by Spacelabs Healthcare (washington), Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medical equipment clinical data interfacing software.

Cleared under the same submission

K110779 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spacelabs Healthcare (washington), Inc

Sources (1)

  • FDA UDI 54726fb5-1a72-4bc1-9d4a-03ff9e390188 35 fields · synced Jun 8, 2026