FDA.reportPublic FDA data

VIVE

Primary DI
00810041981738
Brand
VIVE
Company
VIVE HEALTH LLC
Model
DMD1049
Device description
Pulse Oximeter
Published
2020-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
10810041981735PackageGS1100In Commercial Distribution
00810041981738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081004198173510810041981735
00810041981738008100419817388100419817380810041981738

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen saturation/pulse rate electronic-signal simulatorAn electronic instrument designed to simulate arterial oxygen saturation and/or pulse rate for testing and calibrating pulse oximeters, pulse oximeter probes and other related pulse oximetry devices.

Regulatory Flags#

DUNS number
047025993
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810178888900CoreTechSUP3137BLKXS2026-05-05
00810178888917CoreTechSUP3137BLKS2026-05-05
00810178888924CoreTechSUP3137BLKM2026-05-05
00810178888931CoreTechSUP3137BLKL2026-05-05
00810178888948CoreTechSUP3137BLKXL2026-05-05
00810178888955CoreTechSUP3135BLKXS2026-05-05
00810178888962CoreTechSUP3135BLKS2026-05-05
00810178888979CoreTechSUP3135BLKM2026-05-05
00810178888986CoreTechSUP3135BLKL2026-05-05
00810178888993CoreTechSUP3135BLKXL2026-05-05
00810178889006CoreTechSUP3138BLKXS2026-05-05
00810178889013CoreTechSUP3138BLKS2026-05-05
00810178889020CoreTechSUP3138BLKM2026-05-05
00810178889037CoreTechSUP3138BLKL2026-05-05
00810178889044CoreTechSUP3138BLKXL2026-05-05
00810178889082CoreTechSUP3136BLKXS2026-05-05
00810178889099CoreTechSUP3136BLKS2026-05-05
00810178889105CoreTechSUP3136BLKM2026-05-05
00810178889112CoreTechSUP3136BLKL2026-05-05
00810178889129CoreTechSUP3136BLKXL2026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019919346OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919414OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919421OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
07290019919438OxSat100S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-10-07
00198953009567Carescape ONEGE Healthcare Finland OyDQA2026-10-04
06946725547168APKAPK Technology Co.,Ltd.DQA2026-09-24
06946725571705APKAPK Technology Co.,Ltd.DQA2026-09-20
06946725571903APKAPK Technology Co.,Ltd.DQA2026-09-20
07290016714265SleepSenseS. L. P. SCIENTIFIC LABORATORY PRODUCTS LTDDQA2026-09-08
06946725538005APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725548998APKAPK Technology Co.,Ltd.DQA2026-09-04
06946725572276APKAPK Technology Co.,Ltd.DQA2026-09-04
06944413835153Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
06944413835214Telemetry MonitorEdan Instruments, Inc.DQA2026-08-26
00634782101633Diagnostix™AMERICAN DIAGNOSTIC CORPDQA2026-08-25
06924054300647Medical GuardianSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-21
06946725572221APKAPK Technology Co.,Ltd.DQA2026-08-21
06924054300913BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06924054300920BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-08-18
06970404880000UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880017UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880024UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
06970404880031UpnMedShenzhen Upnmed Equipment Co.,Ltd.DQA2026-08-18
00840118620987Endure IndustriesENDURE INDUSTRIESDQA2026-08-14
06946725572078APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572085APKAPK Technology Co.,Ltd.DQA2026-08-14
06946725572092APKAPK Technology Co.,Ltd.DQA2026-08-14
06924054300906BERRYSHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-07-30
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11