FDA.reportPublic FDA data

VERIDIAN

Primary DI
00845717004435
Brand
VERIDIAN
Company
VERIDIAN HEALTHCARE LLC
Model
11-50K
Catalog number
11-50K
Device description
SmartHeart Economy Pulse Oximeter
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter
OCHOximeter, Infrared, Sporting, Aviation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2
OCHOximeter, Infrared, Sporting, AviationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082641000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082641000FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DLContec Medical System Co., Ltd.2008-11-10DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845717004432PackageGS148In Commercial Distribution
30845717004436PackageGS14In Commercial Distribution
00845717004435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084571700443210845717004432
3084571700443630845717004436
00845717004435008457170044358457170044350845717004435

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device designed to be applied externally to a body site (e.g., fingertip, ear lobe, bridge of nose, toe, or bridge of the foot) for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using signals produced by a light-emitting diode (LED) and received by a photodetector. The signals are subsequently transmitted to an oximeter/monitor (not included) which measures and displays the SpO2. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
1-866-326-1313info@veridianhealthcare.com

Regulatory Flags#

DUNS number
830437997
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845717013574SMARTHEART11-51D2026-09-29
00845717013765SMARTHEART11-51DA2026-09-29
00845717012188Trackstar302-111152026-09-04
00845717013055Trackstar302-1114BSL2026-09-04
00845717013062Trackstar302-1113BB2026-09-04
00845717012171Trackstar302-WS3802026-05-28
00845717015509SmartHeart01-5502026-05-27
00845717012096Trackstar302-2110B2025-09-15
00845717013192SmartHeart UAM-710SH2025-12-12
10845717013199SmartHeart UAM-710SH2025-12-12
00682891216021Zewa216022024-06-21
00682891216014Zewa216012020-04-14
00845717010139Veridian Healthcare11-50Q12025-09-09
30845717010130Veridian Healthcare11-50Q12025-09-09
00845717011785R.P.M. PRO210-1114B2025-09-08
00845717011945R.P.M. PRO210-3110B2025-09-08
00845717012164Trackstar302-1110B2025-09-08
00845717011020Veridian Healthcare01-5742024-09-10
00845717011068R.P.M. PRO210-1113B2025-09-02
00845717011938R.P.M. PRO210-1113C2025-09-02

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
00851697006833ZacurateEINSTEIN ASSOCIATES LLCOCH2026-10-08
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