FDA.reportPublic FDA data

HME Filters

Primary DI
00850057117196
Brand
HME Filters
Company
CORVENT MEDICAL, INC
Model
HME Filters
Catalog number
91-101-US306
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
00850057117196PrimaryGS10
00850057117325Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057117196008500571171968500571171960850057117196
00850057117325008500571173258500571173250850057117325

GMDN Terms#

Term, Definition table
TermDefinition
Heat/moisture exchanger insertable filterA dedicated membrane that is inserted into a reusable heat & moisture exchanger (HME) to capture a patient's exhaled heat and moisture, so that they can be used to heat and humidify therapeutic gases inspired by the patient typically during anaesthesia or intensive care ventilation. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
117496308
Device count
50
Lot or batch
true
Manufacturing 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
00850057117110Flow SensorsFlow Sensors91-101-US2092025-06-05
00850057117172Patient Circuit KitPatient Circuit Kit91-101-US3042025-06-05
00850057117189BV FiltersBV Filters91-101-US3052025-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344102655MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102662MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102679MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102686MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102693MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
10197344102709MEDLINEMEDLINE INDUSTRIES, INC.CBK2025-12-12
09420012477477F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012477491F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480446F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480460F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
09420012480484F&P OptiNIVFISHER & PAYKEL HEALTHCARE LIMITEDCBK2025-12-06
08056814676223DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676247DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676254DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676261DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676377DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676384DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676391DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676407DIMARHMC PREMEDICAL SPACBK2025-03-20
08056814676360DIMARHMC PREMEDICAL SPACBK2025-03-20
10889483603987AirLife™AIRLIFECBK2025-02-26
10889483603994AirLife™AIRLIFECBK2025-02-26
10889483604007AirLife™AIRLIFECBK2025-02-26
10889483604045AirLife™AIRLIFECBK2025-02-26
10889483604052AirLife™AIRLIFECBK2025-02-26
10889483604069AirLife™AIRLIFECBK2025-02-26
10889483604076AirLife™AIRLIFECBK2025-02-26
10889483604083AirLife™AIRLIFECBK2025-02-26
10889483604090AirLife™AIRLIFECBK2025-02-26