FDA.reportPublic FDA data

Oxygen Sensor

Primary DI
04036616011914
Brand
Oxygen Sensor
Company
Honeywell Healthcare Solutions GmbH
Model
R-17Vi
Catalog number
E1002725
Published
2026-08-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082655000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082655000ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106Envitec-Wismar GmbH2008-11-25CCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04036616011914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04036616011914040366160119144036616011914

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.

Regulatory Flags#

DUNS number
330943838
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
false
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04036616011839Oxygen SensorR-43VE10027802026-08-19
04036616011846Oxygen SensorR-48VE10027172026-08-19
04036616011860Oxygen SensorR-22VAE10027192026-08-19
04036616011877Oxygen SensorR-23VE10027202026-08-19
04036616011884Oxygen SensorR-22MEDVE10027222026-08-19
04036616011891Oxygen SensorR-17VE10027232026-08-19
04036616011907Oxygen SensorR-22ViE10027242026-08-19
04036616011921Oxygen SensorR-41VE10027262026-08-19
04036616011938Oxygen SensorR-49VE10027272026-08-19
04036616011945Oxygen SensorT-7VE10027282026-08-19
04036616011952Oxygen SensorR-45VE10027292026-08-19
04036616011969Oxygen SensorR-47VE10027302026-08-19
04036616011976Oxygen SensorR-30VE10027312026-08-19
04036616013482Oxygen SensorR-15VE10028552026-08-19
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyCCL2026-04-15
10889483588635Vital Signs™AirLife Finland OyCCL2025-04-02
10889483588659Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588673Vital Signs™AirLife Finland OyCCL2025-03-31
10889483588697Vital Signs™AirLife Finland OyCCL2025-03-31
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.CCL2024-12-19
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
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyCCL2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyCCL2023-04-19
00195278524089NAGE Healthcare Finland OyCCL2023-04-19
00840682146111CARESCAPE B650GE Healthcare Finland OyCCL2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyCCL2022-05-13