FDA.reportPublic FDA data

Midmark

Primary DI
00841709105883
Brand
Midmark
Company
MIDMARK CORPORATION
Model
IQvitals Zone, Non-Wireless with Masimo SPO2
Catalog number
4-000-0624
Device description
IQvitals Zone, non-Wireless, with Serenity BP, Exergen TemporalScanner and Masimo SpO2
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE
FLLThermometer, electronic, clinical
MWIMONITOR,PHYSIOLOGICAL,PATIENT(WITHOUT ARRHYTHMIA DETECTION OR ALARMS)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
DXNSystem, Measurement, Blood-Pressure, Non-InvasiveCardiovascular2
FLLContinuous Measurement ThermometerGeneral Hospital2
MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)Cardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161909000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161909000IQvitals ZoneMidmark Corporation2016-11-17MWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841709105883PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841709105883008417091058838417091058830841709105883

GMDN Terms#

Term, Definition table
TermDefinition
Single-patient intensive/general healthcare physiologic monitoring systemAn assembly of electrically-powered devices designed for the continuous assessment of several vital physiologic parameters (e.g., ECG, blood pressure, heart rate, temperature, cardiac output, apnoea, and respiratory/anaesthetic gas concentrations) of one patient in intensive or general healthcare settings. It typically includes a central station monitor that receives, consolidates, and displays the information, and/or a bedside patient monitor; it often includes programmable alarms, portable radio transmitters, receivers, and antennas (telemetry systems) to allow monitoring during patient ambulation or transportation; it is not dedicated to neonatal use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)643-6275support@midmark.com

Regulatory Flags#

DUNS number
005036025
Device count
1
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841709105715MidmarkQC3R-01QC3R-012017-06-23
00841709105722MidmarkQC6R-01QC6R-012017-06-23
00841709112577MidmarkDCV5-G2X/HDCV5-G2X/H2021-01-15
00841709112713MidmarkDCV6-G2X/HDCV6-G2X/H2021-01-15
00841709112850MidmarkDCV7-G2X/HDCV7-G2X/H2021-01-15
00841709112928MidmarkDCV8-G2X/HDCV8-G2X/H2021-01-15
00841709112997MidmarkDCVM-G0X/HDCVM-G0X/H2021-01-15
00841709103551MidmarkP7015V-PP7015V-P2017-02-16
00841709103575MidmarkP7016V-PP7016V-P2017-02-16
00841709103599MidmarkP7017V-PP7017V-P2017-02-16
00841709103605MidmarkP7018V-PP7018V-P2017-02-16
00841709108860Midmark153810-001153810-0012026-09-29
00841709108877Midmark153810-002153810-0022026-09-29
00841709108884Midmark153810-003153810-0032026-09-29
00841709109805Midmark153600-020153600-0202026-09-28
00841709109812Midmark153600-021153600-0212026-09-28
00841709109843Midmark153600-304153600-3042026-09-28
00841709109850Midmark153600-305153600-3052026-09-28
00841709109874Midmark153600-504153600-5042026-09-28
00841709109881Midmark153600-505153600-5052026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06953825911942CofoeShenzhen Urion Technology Co., LtdDXN2026-10-20
06953825911928CofoeShenzhen Urion Technology Co., LtdDXN2026-10-19
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06953825911904saidianShenzhen Urion Technology Co., LtdDXN2026-10-14
06974560230655ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-14
06953825911881N/AShenzhen Urion Technology Co., LtdDXN2026-10-13
06974560230648ziqingShenzhen Ziqing Medical Equipment Co.,Ltd.DXN2026-10-13
00850078377302iHealthiHealth Labs Inc.DXN2026-10-12
00850078377326iHealthiHealth Labs Inc.DXN2026-10-12
06953825910501arboleafShenzhen Urion Technology Co., LtdDXN2026-10-10
06973660370520MinttiSuzhou Melodicare Medical Technology Co., Ltd.FLL2026-10-10
06933257920187Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257926066YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257931688YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
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06933257947023Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06933257947030YUWELL Electronic Blood Pressure MonitorJIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.DXN2026-10-09
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
06973826012240AgelhDONGGUAN E-TEST TECHNOLOGY CO.,LTDDXN2026-10-09
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