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.

Endopro Standalonec Capture Workstation · Medical Device Data System → General Hospital

Name: Endopro Standalonec Capture Workstation
Brand: Endopro Standalonec Capture Workstation

11manufacturers in China registered for this device type

1catalogue number

2recalls 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 Endopro Standalonec Capture Workstation
Listed by	Pentax of America, Inc., United States
FDA product code	OUG
Device type	Medical Device Data System
Device class	Class 1
Regulation	21 CFR 880.6310
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2020-03-26

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Endopro Standalonec Capture Workstation
Catalogue number	Size	Status
KBM68346		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
MicroScan	Beckman Coulter, Inc.	9

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

Recalls

2 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
2020-09-22	Class II	Software design	There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially review	39 total	2022-05-16
2020-09-22	Class II	Software design	There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Patient B). This does not occur at the time the user performs and initially review	39 total	2022-05-16

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.

Endopro Standalonec Capture Workstation