FDA.reportPublic FDA data

Diska NuLife

Primary DI
00810115892380
Brand
Diska NuLife
Company
Diska LLC
Model
DNL-YM402
Device description
BLE Pulse Oximeter
Published
2023-10-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810115892403PackageGS1100In Commercial Distribution
00810115892380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810115892403008101158924038101158924030810115892403
00810115892380008101158923808101158923800810115892380

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
006311259
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810115891581Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891697Diska NulifeDNL-TTS012023-08-25
00810115892328Diska NulifeDNL-TMB2084-A2023-10-20
00810115892342Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892427Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892335Diska NulifeDNL-TMB2084-A2023-10-20
00810115892366Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892458Diska NuLifeDNL-VGC012023-10-05
00810115892359Diska NuLifeVGM04(Ref. DNL-VGM04)2023-10-05
00810115892373Diska NuLifeDNL-GBS-2012-B2023-10-05
00810115892403Diska NuLifeDNL-YM4022023-10-05
00810115892441Diska NuLifeVGS01 (REF: DNL-VGS01)2023-10-05
00810115892465Diska NuLifeDNL-VGC012023-10-05
00810115891642Diska NulifeHH-XIII-T2023-08-25
00810115891666Diska NulifeTCS012023-08-25
00810115891710Diska NulifeI2023-08-25
00810115891598Diska NulifeDNL-TMB-2282-G2023-08-25
00810115891659Diska NulifeHH-XIII-T2023-08-25
00810115891673Diska NulifeTCS012023-08-25
00810115891703Diska NulifeDNL-TTS012023-08-25

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