FDA.reportPublic FDA data

O2-Sensor

Primary DI
04250320600084
Brand
O2-Sensor
Company
IT Dr. Gambert GmbH
Model
M-03
Catalog number
41 00 03
Published
2016-08-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CCLAnalyzer, Gas, Oxygen, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCLAnalyzer, Gas, Oxygen, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250320600084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250320600084042503206000844250320600084

GMDN Terms#

Term, Definition table
TermDefinition
Respiratory oxygen sensorA device designed to detect the presence and determine the concentration of oxygen (O2) by paramagnetic, electrochemical, or other technique. The device is typically used as a component of an oxygen monitor or a patient monitoring device/system that determines the percentage of O2 in medical gases used in an enclosed atmosphere (e.g., an anaesthesia or ventilator circuit, oxygen tent, oxygen therapy device/system tubing) inspired by a patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315273537
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250320600985O2-SensorMLF-16DE4714162021-09-24
04250320600602O2-SensorMLF-16H4710162021-09-07
04250320600619O2-SensorM-44PI4703372021-09-07
04250320600626O2-SensorMLF-60HC4100402021-09-07
04250320600633O2-SensorM-03 incl. Flow Diverter4102032021-09-07
04250320600640O2-SensorM-04C4102062021-09-07
04250320600657O2-SensorM-12A4102172021-09-07
04250320600664O2-SensorM-16HTT4702162021-09-07
04250320600725O2-SensorMLF-164703162021-09-07
04250320600732O2-SensorM-16HT4706162021-09-07
04250320600794O2-SensorMLF-154105232021-09-07
04250320600800O2-SensorM-43GE4104042021-09-07
04250320600848O2-SensorMLF-034103032021-09-07
04250320600879O2-SensorM-15M4108232021-09-07
04250320600886O2-SensorM-25F4103202021-09-07
04250320600909O2-SensorM-43GE Dual Pack4103042021-09-07
04250320600916O2-SensorSensors O2 2PK M-43GE4105042021-09-07
04250320600947O2-SensorM-19GE4702422021-09-07
04250320600992O2-SensorM-494100292021-09-07
04250320601012O2-SensorMLF-174702172021-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04036616011983Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-27
04036616011839Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011846Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011860Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011877Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011884Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011891Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011907Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011914Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011921Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011938Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011945Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011952Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011969Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616011976Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
04036616013482Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2026-08-19
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B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
00817770025856MaxBlend2MAXTEC, LLCCCL2024-08-14
10841522108846UltraviewSPACELABS HEALTHCARE (WASHINGTON), INCCCL2024-05-13
10190752191235Vital Signs™AirLife Finland OyCCL2023-05-30
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyCCL2023-04-19
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00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19