FDA.report

MySign® O

Primary DI
04036616009324
Brand
MySign® O
Company
EnviteC-Wismar GmbH
Model
incl. OOM111
Catalog number
1001825
Device description
MySign® O incl. OOM111
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications

CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04036616009324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04036616009324040366160093244036616009324

GMDN Terms

TermDefinition
Respiratory oxygen monitor, line-poweredA mains electricity (AC-powered) instrument designed to continuously measure the concentration of oxygen (O2) inspired by a patient in a respiratory maintenance/therapy setting (e.g., O2 in an anaesthesia or ventilator breathing circuit, oxygen tent, oxygen therapy device/system tubing). It typically consists of an electronic unit with a display to show actual values of percentage of O2 concentration, a sensor to detect the O2 values, control knobs or buttons, and an alarm to alert when O2 values are beyond a predetermined range; it may also include appropriate temperature-compensated electrodes.

Device Sizes

TypeValueUnit
Height42Millimeter
Length166Millimeter
Width242Millimeter

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure75 KiloPascal125 KiloPascal
Handling Environment Temperature0 Degrees Celsius50 Degrees Celsius
Storage Environment Atmospheric Pressure75 KiloPascal125 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity99 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
330943838
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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04036616010900Oxygen SensorOOMLF204E10025732022-06-17
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04036616000604Disposable SensorDA-2251-1 Datex08-00-01312016-09-22
04036616005494Disposable SensorDA-2211-1 Nellcor08-00-04682016-09-22
04036616005982Disposable SensorDA-2231-1 Nonin08-00-01272016-09-22
04036616007146Disposable SensorDA-2221-1 OEM BCI08-00-03232016-09-22
04036616007214Disposable SensorDA-2231-1 OEM Nonin08-00-03332016-09-22
04036616007528Disposable SensorDA-2211-1 OEM Nellcor08-00-04782016-09-22
04036616009331Disposable SensorDA-2211-1L Nellcor10018342016-09-22
04036616009874MySign® Swo/power supply FDA10021972016-09-22
04036616010054Disposable SensorDA-2211-1 MySign® FDA10022152016-09-22
04036616010207Disposable sensorDA-2203-1 Nihon Kohden US10023242016-09-22
04036616013505Oxygen SensorOOMLF101-ME10028572021-05-03
04036616001830SoftTip® largeR-2182-3 Minolta06-00-01152016-09-22
04036616001854SoftTip® largeR-2203-16 Nihon Kohden06-00-10702016-09-22
04036616001861SoftTip largeR-2412 HP/Philips06-00-07252016-09-22
04036616001885SoftTip largeR-2414-15 HP/Philips06-00-07232016-09-22
04036616001908SoftTip largeR-3212-9 Nellcor06-00-07112016-09-22
04036616001939SoftTip largeR-3212-31 Nellcor06-00-07092016-09-22
04036616001946SoftTip largeR-3222-12 BCI06-00-05842016-09-22

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