FDA.reportPublic FDA data

MySign® S

Primary DI
04036616010085
Brand
MySign® S
Company
Honeywell Healthcare Solutions GmbH
Model
inkl. DA-2211-1 MySign® FDA
Catalog number
1002218
Device description
MySign® S inkl. DA-2211-1 MySign® FDA
Published
2016-09-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

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
04036616010085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616010085040366160100854036616010085

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height42Millimeter
Length166Millimeter
Width242Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+3841360324christian.walsleben@honeywell.com

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
04036616010948Oxygen SensorOOMLF102-M3E10026032020-03-03
04036616013895Oxygen SensorOOM113-ME10029542025-11-12
04036616010856Oxygen SensorOOMLF111-HE10025382025-04-28
04036616013871Oxygen SensorOOMLF204-DE10029522025-04-28
04036616000581Disposable SensorDA-2221-1 BCI08-00-01232016-09-22
04036616007146Disposable SensorDA-2221-1 OEM BCI08-00-03232016-09-22
04036616010207Disposable sensorDA-2203-1 Nihon Kohden US10023242016-09-22
04036616001939SoftTip largeR-3212-31 Nellcor06-00-07092016-09-22
04036616001946SoftTip largeR-3222-12 BCI06-00-05842016-09-22
04036616002066SoftTip largeR-3512-40 Datex06-00-07272016-09-22
04036616002073SoftTip largeR-3512-9 Datex06-00-07662016-09-22
04036616002127SoftTip smallRS-2182-3 Minolta06-00-05912016-09-22
04036616002158SoftTip smallRS-2412 HP/Philips06-00-07262016-09-22
04036616002202SoftTip smallRS-3222-12 BCI06-00-05832016-09-22
04036616002257SoftTip smallRS-3412 Ohmeda06-00-07162016-09-22
04036616002264SoftTip smallRS-3412-10 Ohmeda06-00-08222016-09-22
04036616002295SoftTip smallRS-3512-40 Datex06-00-07292016-09-22
04036616002301SoftTip smallRS-3512-9 Datex06-00-08152016-09-22
04036616002349SoftTip® mediumRM-2182-3 Minolta06-00-13612016-09-22
04036616002370SoftTip® mediumRM-2412 HP/Phillips06-00-13642016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048675785910Masimo SpO2 Module for Vista 300/SShanghai Draeger Medical Instrument Co.,Ltd.DQA2026-07-13
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09