FDA.report

TMS-6016 Telemetry Monitoring System

Primary DI
06944904008271
Brand
TMS-6016 Telemetry Monitoring System
Company
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Model
TMS-6016
Published
2015-10-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
MSXSystem,Network And Communication,Physiological Monitors

Product Code Classifications

CodeDeviceSpecialtyClass
MSXSystem, Network And Communication, Physiological MonitorsCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06944904008271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06944904008271069449040082716944904008271

GMDN Terms

TermDefinition
Multiple-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of more than one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and bedside patient monitors to provide data from each patient; it often includes programmable alarms, portable radio transmitters (with sensors), receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation.

Sterilization Methods

Method

Regulatory Flags

DUNS number
654671304
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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