What is FDA product code OUG?

A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

General Hospital › MiscellaneousMedical Device Data System

MicroScan

Name: MicroScan
Brand: MicroScan

DVD, LabPro V4.42 Panel Update-08 (US); LabPro V4.42 Panel Update-08 DVD Kit (US); LabPro V4.42 System Kit w/Panel Update-08 (US)

Registry build 21.09.26

11manufacturers in China registered for this device type

9catalogue numbers in this listing

4recalls on this code

Who Else Makes It

Concentrated in Guangdong (4), Shanghai (3), Jiangsu (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code OUG
Manufacturer	City	Province	Registered as	Device types
Edan Instruments, Inc.	Shenzhen	Guangdong	Contract manufacturer	56
Jabil Circuit (Shanghai) Ltd.	Shanghai	Shanghai	Contract manufacturer	31
Dongguan BAO Kang Dian ZI KE JI Limited	Dongguan	Guangdong	Contract manufacturer	24
Primecare Medical (Suzhou) Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	20
Shenzhen Insighters Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	10
Changshu Rozer Sterilization Technology Co., Ltd.	Changshu	Jiangsu	Contract manufacturer	43
Hangzhou Primecare Medical Co., Ltd.	Hangzhou	Zhejiang	Contract manufacturer	29
Shanghai Mediworks Precision Instruments Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	13
Zhejiang Yigao Medical Technology Co., Ltd.	Hangzhou	Zhejiang	Manufacturer	7
Resvent Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	6
Shanghai Draeger Medical Instrument Co., Ltd.	Shanghai	Shanghai	Contract manufacturer	4

Record

Regulatory record for MicroScan
Listed by	Beckman Coulter, Inc., United States
FDA product code	OUG
Device type	Medical Device Data System
Device class	Class 1
Regulation	21 CFR 880.6310
Establishment	Contract manufacturer, Specification developer, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2024-02-15
Record revised	2022-09-16 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, manufacturing date
Packaging	6000-0060, 6000-0052, 6000-0072, 6000-0051, 6000-0050

Catalogue Numbers

Catalogue numbers for MicroScan
Catalogue number	Size	Status
V4_V5		In distribution
v5.00		In distribution
V4.42		In distribution
V4.42		In distribution
V4.42MUA		In distribution
V4.42		In distribution
V4_V5		In distribution
V2.0		In distribution
V4.42		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Responder	Rauland-Borg Corporation	170
Medical Device Data System	Pentax of America, Inc.	72
DreamStation	Respironics Inc.	55
Endopro IQ	Pentax of America, Inc.	49
MonitAir	Monitair, LLC	22
Medical Device Data System	Medtronic, Inc.	20
DreamMapper	Respironics Inc.	16
Arthrex®	Arthrex, Inc.	14
Visionflex	Visionflex PTY Limited	11
Intesys Clinical Suite	Spacelabs Healthcare (Washington), Inc	11
myoncare	Oncare GmbH	9
Broadband	Respironics Inc.	8

Showing 12 of 281. All products under Medical Device Data System

Recalls

4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-01-17	Class II	Software Manufacturing/Software Deployment	A security-only update was released via remote diagnostics on January 14, 2020 to customers with Windows 7 operation system. Shortly after the releases some customers reported that Data Management System computers would not restart. If the	177 systems	2021-04-27
2016-10-25	Class II	Device Design	Beckman Coulter has received and confirmed reports of an intermittent and unexpected behavior when loading new panels into a WalkAway instrument using LabPro Data Management System version 4.42. The issue could cause workflow interruption	131 units total (130 units in US)	2017-05-01
2016-02-11	Class II	Unknown/Undetermined by firm	Beckman Coulter is recalling the MicroScan LabPro Information Manager System because the software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with a	2,702 units total (1,032 units in US)	2018-01-04
2015-07-17	Class II	Unknown/Undetermined by firm	The software incorrectly allows the operator to manually edit the carbohydrate substrates when manually reading dried overnight gram negative panels with an ID Hold status.	2,456 units total (1,034 units total)	2018-01-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.