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.

Trilogy 200 · Medical Device Data System → General Hospital

Name: Trilogy 200
Brand: Trilogy 200

11manufacturers in China registered for this device type

2catalogue numbers in this listing

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 Trilogy 200
Listed by	Respironics 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, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter
510(k)	K093416
Record published	2016-09-23
Record revised	2021-03-01 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number
Storage	Storage environment humidity 15 to 95 % RH; Storage environment temperature -4 to 140 °F
Distribution end date	2021-02-28

Catalogue Numbers

Catalogue numbers for Trilogy 200
Catalogue number	Size	Status
Trilogy 200 Ventilator, Italy, Bluetooth		In distribution
Trilogy 200 Ventilator, Japan-Recert		Withdrawn

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 Naming This Product

5 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Trilogy 200
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity	Closed
Respironics Inc.	510(k) number	2022-12-07	Class I	Process design	The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which c	537 devices
Respironics Inc.	510(k) number	2021-06-14	Class I	Device Design	The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.	255810
Philips Respironics, Inc.	510(k) number	2016-01-18	Class II	Software design	Software Issue	104,508 units	2017-05-26
Respironics Inc.	510(k) number	2014-02-11	Class I	Component design/selection	Internal testing revealed a potentially defective component on the power management board that could affect the function of certain Trilogy Ventilators resulting in loss of therapy to patients.	572	2015-04-17
Respironics Inc.	510(k) number	2012-04-27	Class I	Component design/selection	The specified Trilogy units are being recalled because of the potential for a faulty component in the power supply.	173	2012-11-01

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.

Trilogy 200