FDA.reportPublic FDA data

Ear Clip easy

Primary DI
07640121880810
Brand
Ear Clip easy
Company
SenTec AG
Model
ECe-MI
Device description
Single patient use sensor application ear clip, recommended for adult, pediatric and neonatal patients with mature/intact skin
Published
2020-03-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, Ear
DQAOximeter
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
LKDMonitor, Carbon-Dioxide, Cutaneous
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2
DQAOximeterCardiovascular2
KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas AnesthesiaAnesthesiology2
LKDMonitor, Carbon-Dioxide, CutaneousAnesthesiology2
LPPMonitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041548000
K071672000
K101690000
K151329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041548000SENTEC DIGITAL MONITOR MODEL #SDMSentec, Inc.2004-08-09LKD
K071672000SENTEC DIGITAL MONITORING SYSTEMSentec AG2007-09-12DQA
K101690000SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLESentec AG2010-12-03LKD
K151329000SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNetSentec AG2015-12-17LKD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17640121880817PackageGS124Not in Commercial Distribution
07640121880810PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1764012188081717640121880817
07640121880810076401218808107640121880810

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeter probe, reusableA photoelectric component of a pulse Co-oximeter that is applied externally to a body part (e.g., a fingertip for adults, the hand or foot for neonates), for the transcutaneous multiwave measurement of carboxy-haemoglobin saturation (SpCO) and typically several other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), haemoglobin concentration (SpHb), haematocrit, and pulse rate using light detection. Signals from the probe, produced by a light-emitting diode (LED) and a receiving detector, are used to calculate results which are digitally displayed on the Co-oximeter's computerized unit. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Temperature during transport: 0-50°C
Storage Environment Humidity10 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
480797856
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640121880803Multi-Site Attachment Ring for fragile/sensitive skinMARe-SF2019-01-29
07640121880964Patient Application Kit for mature intact skinPAK-MI2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinPAK-SF2021-09-26
07640121881039Non-Adhesive Wrap1035202023-07-21
07640121880988103149 Calibration Gas1031492024-07-05
07640121880995103164 tCOM+1031642024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)1034202024-07-05
07640121881015103421 Sensor Adapter Cable (Long)1034212024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)1034222024-07-05
07640121880957Patient Application Kit with Ear Clip for mature/intact skinPAK-EC2021-09-26
07640121880889SDM Water Protection CoverSDM_WPC2021-08-25
07640121880902Isolation Transformer 100-120VRFT100VA-V12021-05-05
07640121880933Membrane Changer (single-use) / single unitMC2021-02-28
17640121880862Contact GelGEL-SD2019-03-05
07640121880018Sentec Digital MonitorSDM2016-08-31
07640121880032Digital Sensor Adapter Cable, 150 cmAC-1502016-08-31
07640121880049Ear ClipEC-MI2016-08-31
07640121880056Service gasGAS-08122016-08-31
07640121880070Contact GelGEL-042016-08-31
07640121880087Membrane Changer (reloadable) / single unitMC-R2016-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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