FDA.reportPublic FDA data

Flow Sensors

Primary DI
00850057117110
Brand
Flow Sensors
Company
CORVENT MEDICAL, INC
Model
Flow Sensors
Catalog number
91-101-US209
Published
2025-06-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CBKVentilator, Continuous, Facility UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241135000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241135000RESPOND(R) VentilatorCorvent Medical, Inc.2024-11-13CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850057117110PrimaryGS10
00850057117363Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057117110008500571171108500571171100850057117110
00850057117363008500571173638500571173630850057117363

GMDN Terms#

Term, Definition table
TermDefinition
Breathing circuit gas-flow sensor, reusableA device that includes a transducer intended to detect the movement of gases in a breathing circuit, and convert this into an electrical signal for relay to a ventilator (e.g., adult/paediatric/neonatal ventilators, anaesthesia system ventilators). It is connected to the breathing circuit and an appropriate data transfer cable and intended to enable the ventilator to display/monitor the gas flow to and from the patient, whereby controlled adjustments may be made. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
(833)770-8368support@corventmedical.com

Regulatory Flags#

DUNS number
117496308
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850057117493Cart, Display Enclosure 11 inchCart, Display Enclosure 11 inch91-101-US3212026-05-26
00850057117509CorVision with DisplayCorVision with Display91-101-US3232026-05-26
00850057117516CorVent® CorVision1.0.02026-05-19
00850057117431HEPA FiltersHEPA Filters (Pk of 50)91-101-US5052026-01-06
00850057117370RESPOND VentilatorRESPOND Ventilator91-101-US1002026-01-06
00850057117387Flow SensorFlow Sensor91-101-US5032026-01-06
00850057117394RESPOND Exhalation ManifoldRESPOND Exhalation Manifold91-101-US5012026-01-06
00850057117400Exhalation ValveExhalation Valve91-101-US5022026-01-06
00850057117417RESPOND HME Patient Circuit Kit (Tubing, Connector & HME/RESPOND HME Patient Circuit Kit (Tubing, Connector91-101-US5042026-01-06
00850057117424HEPA FiltersHEPA Filters (Pk of 50)91-101-US5052026-01-06
00850057117448Green Oxygen Hose, 8ftGreen Oxygen Hose, 8ft91-101-US2122026-01-06
00850057117455Oxygen Tubing with Connector, 7ftOxygen Tubing with Connector, 7ft91-101-US2132026-01-06
00850057117462Cart, IV Power StripCart, IV Power Strip91-101-US3192026-01-06
00850057117479Cart, IV Power Strip MountCart, IV Power Strip Mount91-101-US3182026-01-06
00850057117486Patient Circuit Arm ClipPatient Circuit Arm Clip91-101-US3202026-01-06
00850057117059RESPOND Exhalation ManifoldRESPOND Exhalation Manifold91-101-US2022025-06-05
00850057117080Lint FiltersLint Filters91-101-US2062025-06-05
00850057117172Patient Circuit KitPatient Circuit Kit91-101-US3042025-06-05
00850057117189BV FiltersBV Filters91-101-US3052025-06-05
00850057117196HME FiltersHME Filters91-101-US3062025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
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09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
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08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
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