FDA.reportPublic FDA data

Ear Sensor

Primary DI
04036616009973
Brand
Ear Sensor
Company
Honeywell Healthcare Solutions GmbH
Model
ES-3211-12 MySign® FDA
Catalog number
1002207
Device description
Ear Sensor ES-3211-12 MySign® FDA
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DPZOximeter, Ear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DPZOximeter, EarCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04036616009973PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616009973040366160099734036616009973

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height40Millimeter
Length140Millimeter
Width130Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
330943838
Device count
1
DM exempt
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04036616011983Oxygen SensorR-45VE10027322026-08-27
04036616011839Oxygen SensorR-43VE10027802026-08-19
04036616011846Oxygen SensorR-48VE10027172026-08-19
04036616011860Oxygen SensorR-22VAE10027192026-08-19
04036616011877Oxygen SensorR-23VE10027202026-08-19
04036616011884Oxygen SensorR-22MEDVE10027222026-08-19
04036616011891Oxygen SensorR-17VE10027232026-08-19
04036616011907Oxygen SensorR-22ViE10027242026-08-19
04036616011914Oxygen SensorR-17ViE10027252026-08-19
04036616011921Oxygen SensorR-41VE10027262026-08-19
04036616011938Oxygen SensorR-49VE10027272026-08-19
04036616011945Oxygen SensorT-7VE10027282026-08-19
04036616011952Oxygen SensorR-45VE10027292026-08-19
04036616011969Oxygen SensorR-47VE10027302026-08-19
04036616011976Oxygen SensorR-30VE10027312026-08-19
04036616013482Oxygen SensorR-15VE10028552026-08-19
04036616010948Oxygen SensorOOMLF102-M3E10026032020-03-03
04036616013895Oxygen SensorOOM113-ME10029542025-11-12
04036616010856Oxygen SensorOOMLF111-HE10025382025-04-28
04036616013871Oxygen SensorOOMLF204-DE10029522025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyDPZ2026-04-15
00195278984784TruSignal SpO2GE Healthcare Finland OyDPZ2025-06-16
00860008683236OxiWearOXIWEAR, INC.DPZ2025-06-04
05700693918808TCM 4 series ETX base unitRadiometer Medical ApSDPZ2025-04-23
07640121880988103149 Calibration GasSenTec AGDPZ2024-07-05
07640121880995103164 tCOM+SenTec AGDPZ2024-07-05
07640121881008103420 Sensor Adapter Cable (Regular)SenTec AGDPZ2024-07-05
07640121881015103421 Sensor Adapter Cable (Long)SenTec AGDPZ2024-07-05
07640121881022103422 Sensor Adapter Cable (Extra Long)SenTec AGDPZ2024-07-05
00195278561312Portrait VSMGe Medical Systems Information Technologies, Inc.DPZ2024-05-05
07640121881039Non-Adhesive WrapSenTec AGDPZ2023-07-21
17640121881036Non-Adhesive WrapSenTec AGDPZ2023-07-21
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyDPZ2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyDPZ2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyDPZ2023-04-19
00195278524089NAGE Healthcare Finland OyDPZ2023-04-19
00195278288639CARESCAPE ONEGe Medical Systems Information Technologies, Inc.DPZ2022-05-13
00840682146111CARESCAPE B650GE Healthcare Finland OyDPZ2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyDPZ2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyDPZ2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.DPZ2022-04-12
07640121880964Patient Application Kit for mature intact skinSenTec AGDPZ2021-09-26
07640121880971Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
07640121880957Patient Application Kit with Ear Clip for mature/intact skinSenTec AGDPZ2021-09-26
17640121880978Patient Application Kit for sensitive/fragile skinSenTec AGDPZ2021-09-26
00840682147248TruSignal SpO2GE Healthcare Finland OyDPZ2021-09-03