Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2134715

FEI Number

3003007937

Entity Name

TreyMed, Inc.

City/State/Country

Sussex, WI, US

Establishment Address

N56 W 24790 N. CORPORATE CIR., No. C, Sussex, WI 53089, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

TreyMed, Inc. (Owner Number: 9034491)

Owner / Operator Contact Address

N56 W 24790 N. CORPORATE CIR., --, Sussex, WI 53089, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Virtus Flow Sensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2025-12-12
BZL	Computer, Oxygen-Uptake	Anesthesiology	Class 2	868.1730	2025-12-12
BTY	Calculator, Predicted Values, Pulmonary Function	Anesthesiology	Class 2	868.1890	2015-01-09
CBK	Ventilator, Continuous, Facility Use	Anesthesiology	Class 2	868.5895	2016-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TreyMed, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K802417	Siemens Elema AB	AB O2 CONSUMPTION CALCULATOR 980	1980-10-23
K051895	Datex-Ohmeda, Inc.	GE DATEX-OHMEDA ENGSTROM CARESTATION	2005-09-27
K082966	Covidien, Formerly Nellcor Puritan Bennett, Inc.	PB 540 VENTILATOR	2008-10-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-2015	Respironics California Inc	2	Esprit V1000 and V200 Ventilators, Model No. V1000 and V200; and the 3rd Generation Power Supply Repair Part (RP)Kits Microprocessor-controlled, electrically powered mechanical ventilators intended for use by qualified medical personnel to provide continuous or intermittent ventilator support for adult, pediatric and neonatal patients as prescribed by a physician.
Z-0018-2011	Draeger Medical Systems, Inc.	2	Oxylog 3000, Emergency and Transport Ventilator; Catalog #2M86300; Drager Medical Inc., 3135 Quarry Road, Telford, PA 18969.
Z-0112-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
Z-0180-2015	Nellcor Puritan Bennett Inc. (dba Covidien LP)	2	Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
Z-0338-2022	Covidien Llc	2	Puritan Bennett 980 Series Ventilator, 980A1ENNISB

Similar Registrations

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1314417	SunMed Group Holdings, LLC	Grand Rapids, MI, US
9615102	Jaeger Medical GmbH	HOECHBERG Bavaria, DE
8021084	COSMED S.R.L.	ALBANO LAZIALE, ROMA, IT

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2134715. Last updated year: 2026. Please use registration number 2134715 when referencing this establishment in official correspondence.