FDA.reportPublic FDA data

Dagamma

Primary DI
00628055787457
Brand
Dagamma
Company
DAGAMMA INC.
Model
Finger Pulse Oximeter DP250
Device description
The Dagamma DP250 finger pulse oximeter is a lightweight, portable device used for measuring both heart rate and blood oxygen levels or SpO2 and Perfusion Index
Published
2020-05-28
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
10628055787454PackageGS11In Commercial Distribution
20628055787451PackageGS1100In Commercial Distribution
00628055787457PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1062805578745410628055787454
2062805578745120628055787451
00628055787457006280557874576280557874570628055787457

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
080572190
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628055787389DagammaFinger Pulse Oximeter DP-100 Blue2017-03-30
00628055787396DagammaFinger Pulse Oximeter DP-100 Black2017-03-30
00628055787402DagammaFinger Pulse Oximeter DP-100 White2017-03-30
00628055787426DagammaFinger Pulse Oximeter DP-100 Yellow2017-03-30
00628055787433DagammaFinger Pulse Oximeter DP-100 Pink2017-03-30
00628055787570DagammaFinger Pulse Oximeter DP-150 Blue2017-10-06
00628055787587DagammaFinger Pulse Oximeter DP-150 Black2017-10-06
00628055787594DagammaFinger Pulse Oximeter DP-150 White2017-10-06
00628055787617DagammaFinger Pulse Oximeter DP-150 Yellow2017-10-06
00628055787624DagammaFinger Pulse Oximeter DP-150 Pink2017-10-06
00628055787440DagammaFinger Pulse Oximeter DP2002020-05-28
10628055787454DagammaFinger Pulse Oximeter DP2502020-05-28
00628055787839BabyTemp by Baby DopplerDuoSmart Thermometer2020-05-28
00628055787242Baby DopplerBabyTemp 1 Sec ThermometerAL65005002019-05-23
00628055787259DagammaDT10002017-03-30
00628055787013Baby DopplerSonoline B Blue 3MHz2017-03-30
00628055787051Baby DopplerSonoline B Pink 3MHz2017-03-30
00628055787266Baby DopplerUltraline 1000 Blue 2.5MHz2017-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
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
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
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