FDA.reportPublic FDA data

Innovo

Primary DI
00851697006253
Brand
Innovo
Company
Innovo Medical
Model
m900BP
Catalog number
M430N-CPWH-CMIM
Device description
Innovo® m900BP Prescription Medical Pulse Oximeter with Plethysmograph and Perfusion Index
Published
2018-07-30
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851697006253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851697006253008516970062538516970062530851697006253

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8588889781cs@innovogroups.com

Regulatory Flags#

DUNS number
080053362
Device count
1
Lot or batch
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851697006000Innovo430J/PEM430N-PEWH-JPIM2017-03-14
00851697006048InnovoCMS 50F PlusCMS50FPLUSBT2016-09-23
00851697006123Innovo430C/DL-PEM430N-CEWH-CMIM2016-09-23
00851697006178InnovoiP900APM430N-PEWH-JPIM2017-10-30
00851697006062InnovoiSoothe E-946R-5E-946R-52016-09-23
00851697006192InnovoJapanese Gel - 4 piecesM946N-04WH-TRIM2017-10-30
00851697006208InnovoJapanese Gel - 44 piecesM946N-44WH-TRIM2017-10-30
00851697006222InnovoiT300AG-SM942N-GSWH-DDIM2018-08-31
00851697006239InnovoiT300AG-LM942N-GLWH-DDIM2018-08-31
00851697006093InnovoINV-EF10010499EF2016-09-23
00851697006130InnovoINV-FR201M499N-F1WH-JPIM2016-11-22
00851697006154InnovoINV-EF100499EFv22017-01-06
00851697006185InnovoINV-EF100M499N-E2SI-JPIM2017-03-31
00851697006031InnovoiSoothe INV-942R942R-O2016-09-23
00851697006215InnovoiT300ABM942N-WBWH-DDIM2018-08-31
00851697006024InnovoZBH-BULBB370N-AACL-JPIM2016-09-23

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Primary DI, Brand, Company table
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06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03