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Universal Data Acquisition System

FDA UDI

Class II (US FDA UDI)

by Clinicomp International, Inc.

Identity

Trade Name
Universal Data Acquisition System FDA UDI
Generic Name
Centralized patient monitor FDA UDI
Model / Reference
UDAS17 FDA UDI

Identifiers

Primary DI / UDI-DI
B321598107300 FDA UDI
510(k) Number
K931133 FDA UDI
FDA Product Code
HGM FDA UDI
GMDN Term
Centralized patient monitor FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
884.2740 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

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Weight — 1.13 Pound FDA UDI
Depth — 1.875 Inch FDA UDI
Height — 4.5 Inch FDA UDI
Width — 8.25 Inch FDA UDI

Category: Centralized patient monitor

Universal Data Acquisition System by Clinicomp International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Centralized patient monitor.

Cleared under the same submission

K931133 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clinicomp International, Inc.

Sources (1)

  • FDA UDI 5fbaac02-1929-4b73-9c2d-969440be2280 36 fields · synced May 30, 2026