BEUDAMED

FDA UDI Not in Commercial Distribution 🇺🇸 United States

Ear Sensor

DI: 04036616010030 · Model: ES-3212-9 MySign® FDA · Honeywell Healthcare Solutions GmbH

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Product Codes

1

GMDN Terms

1

Identifiers

1

Pkg Device Count

1

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Basic Information

Brand Name: Ear Sensor
Primary DI: 04036616010030
Version / Model: ES-3212-9 MySign® FDA
Catalog Number: 1002213
Company Name: Honeywell Healthcare Solutions GmbH
Labeler DUNS: 330943838
Distribution Status: Not in Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-09-22
Public Version: 7
Public Version Date: 2025-04-24
Public Version Status: Update
Public Device Record Key: 3d45a643-1851-454c-acb7-89b17b93d1ae
Distribution End Date: 2025-01-01

Device Description

Ear Sensor ES-3212-9 MySign® FDA

Device Characteristics

Single Use: No
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: MR Unsafe
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DPZ	Oximeter, Ear	Cardiovascular	870.2710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37808	Pulse oximeter probe, reusable	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04036616010030	GS1

Device Sizes

Type	Value	Unit	Text
Height	40	Millimeter
Length	140	Millimeter
Width	130	Millimeter

Storage Conditions

Type: Handling Environment Temperature
Temperature Range: 5 – 40 Degrees Celsius
Type: Storage Environment Humidity
Temperature Range: 15 – 95 Percent (%) Relative Humidity
Type: Storage Environment Temperature
Temperature Range: -20 – 70 Degrees Celsius