FDA.reportPublic FDA data

Q-Tel RMS

Primary DI
00812345029505
Brand
Q-Tel RMS
Company
MORTARA INSTRUMENT, INC.
Model
QTELM-P-AAXA
Device description
Cardiac and pulmonary rehabilitation data acquisition and editing system
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSIDetector And Alarm, Arrhythmia
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSIDetector And Alarm, ArrhythmiaCardiovascular2
MHXMonitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K003576000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K003576000Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503Quinton, Inc.2001-01-25DSI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812345029505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812345029505008123450295058123450295050812345029505

GMDN Terms#

Term, Definition table
TermDefinition
Electrocardiography telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit electrocardiographic (ECG) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Fahrenheit113 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-667-8272techsupport@mortara.com

Regulatory Flags#

DUNS number
062046149
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812345023050Snap Adapter9281-002-502016-09-24
00817655020099WAM30012-020-602016-09-24
00817655020150WAM30012-020-512016-09-24
00817655020266WAM41000-034-502016-10-06
00817655020273WAM41000-034-512016-10-06
00817655020471WAM41000-029-522016-10-25
00817655020518WAM41000-029-602016-11-07
00817655020525WAM41000-029-612016-11-07
00817655020532WAM41000-029-702016-11-07
00817655020549WAM41000-029-712016-11-07
00817655021959WAM30012-019-4502017-09-08
00817655022031WAM30012-019-752017-09-19
00817655022048AM1241000-032-542017-09-19
00817655022055AM1241000-032-562017-09-19
00817655022062WAM41000-031-542017-09-19
00817655022079WAM41000-031-562017-09-19
00817655022741WAM41000-038-502017-11-14
00817655023137AM129293-048-652018-03-29
00812345021745WAM41000-031-502016-09-24
00812345021752WAM41000-031-522016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04538612209543FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226113FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612226922FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612228070FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230370FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.MHX2026-07-17
04538612230387FUKUDA DENSHIFUKUDA DENSHI CO.,LTD.DSI2026-07-17
00884838132320Patient Information Center iXPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132337Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHMHX2026-07-13
00884838132344Care AssistPhilips Medizin Systeme Böblingen GmbHDSI2026-07-13
04048675723639Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675723646Vista 300Shanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675785477Vista CMSShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
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04048675797173Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797180Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
04048675797197Vista 300 SShanghai Draeger Medical Instrument Co.,Ltd.MHX2026-07-13
00198953205716CARESCAPE Telemetry ServerGe Medical Systems Information Technologies, Inc.MHX2026-06-05
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