FDA.report

Sensoronics

Primary DI
00851456007149
Brand
Sensoronics
Company
SENSORONICS INCORPORATED
Model
SS-26
Published
2016-09-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
00851456007149PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00851456007149008514560071498514560071490851456007149

GMDN Terms

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

Regulatory Flags

DUNS number
079579147
Device count
1
DM exempt
false
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00851457007292SensoronicsSBPM-502019-09-27
00851457007278SesoronicsSPO5002019-09-27
00851457007285SensoronicsSPO502019-09-27
00851456007156SensoronicsSB-BCI-3A2016-09-26
00851456007163SensoronicsSB-BCI-3P2016-09-26
00851456007170SensoronicsSB-MALNC-3A2016-09-26
00851456007187SensoronicsSB-MALNC-3P 2016-09-26
00851456007194SensoronicsSB-MALNC-9A2016-09-26
00851456007200SensoronicsSB-MALNC-9P2016-09-26
00851456007217SensoronicsSB-NCRO-3A2016-09-26
00851456007224SensoronicsSB-NCRO-3P2016-09-26
00851456007231SensoronicsSB-NCRO-9A2016-09-26
00851456007248SensoronicsSB-NCRO-9P 2016-09-26
00851456007255SensoronicsSB-NCRON-3A 2016-09-26
00851456007262SensoronicsSB-NON-3A 2016-09-26
00851456007279SensoronicsSB-NON-3P2016-09-26
00851456007286SensoronicsSB-OHM-3A2016-09-26
00851456007293SensoronicsSB-OHM-3P 2016-09-26
00851456007309SensoronicsSB-OHM-9A 2016-09-26
00851456007316SensoronicsSB-OHM-9P 2016-09-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06944413838406Patient Monitor Edan Instruments, Inc.CCL2025-09-05
04036616010856Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
04036616013871Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2025-04-28
10889483588628Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590058Vital Signs™AirLife Finland OyCCL2025-04-07
10889483590065Vital Signs™AirLife Finland OyCCL2025-04-07
20889483588632Vital Signs™AirLife Finland OyCCL2025-04-02
20889483588656Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588670Vital Signs™AirLife Finland OyCCL2025-03-31
20889483588694Vital Signs™AirLife Finland OyCCL2025-03-31
00817770025665Oxygen SensorMAXTEC, LLCCCL2024-08-14
00817770025849AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025931AnalyzerMAXTEC, LLCCCL2024-08-14
00817770025948AnalyzerMAXTEC, LLCCCL2024-08-14
04036616009102Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
04036616010979Oxygen SensorHoneywell Healthcare Solutions GmbHCCL2024-08-14
00813841022281Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00813841022298Bio-Med Devices, Inc.BIO-MED DEVICES, INC.CCL2023-06-12
00817770025641Oxygen SensorMAXTEC, LLCCCL2023-06-08
00817770025658MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025689MaxVenturiMAXTEC, LLCCCL2023-06-08
00817770025788Oxygen SensorMAXTEC, LLCCCL2023-06-08
10190752190955Vital Signs™Vyaire Medical OyCCL2023-05-30
10190752190962Vital Signs™Vyaire Medical OyCCL2023-05-30
70190752191237Vital Signs™Vyaire Medical OyCCL2023-05-30
04036616010900Oxygen SensorEnviteC-Wismar GmbHCCL2022-06-17
00852470008150Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
00852470008174Teledyne Analytical InstrumentsTeledyne Analytical InstrsCCL2022-04-06
B9671501000S3AAei Technologies, Inc.CCL2021-11-03
04250320600985O2-SensorIT Dr. Gambert GmbHCCL2021-09-24