FDA.reportPublic FDA data

BV Filters

Primary DI
00850057117301
Brand
BV Filters
Company
CORVENT MEDICAL, INC
Model
BV Filters
Catalog number
91-101-US305
Published
2025-06-05
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

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
00850057117189PrimaryGS10
00850057117301Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057117189008500571171898500571171890850057117189
00850057117301008500571173018500571173010850057117301

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117496308
Device count
50
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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