FDA.reportPublic FDA data

RESPOND Exhalation Manifold

Primary DI
00850057117349
Brand
RESPOND Exhalation Manifold
Company
CORVENT MEDICAL, INC
Model
RESPOND Exhalation Manifold
Catalog number
91-101-US202
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
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
00850057117059PrimaryGS10
00850057117349Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057117059008500571170598500571170590850057117059
00850057117349008500571173498500571173490850057117349

GMDN Terms#

Term, Definition table
TermDefinition
Transport electric ventilatorAn electrically-powered device designed to provide automated, alveolar ventilatory support for patients during interhospital or intrahospital transport, and in emergency situations. It is typically a compact, lightweight, rugged device with internal batteries to power it during patient transport. It typically provides mandatory breaths at pre-set intervals (control mode), not allowing the patient to breathe spontaneously; operation in assist/control and/or synchronized intermittent mandatory ventilation (SIMV) modes is available in some types. It usually includes an airway pressure monitor and low and high pressure alarms; it may be used in ambulances, and in field hospitals.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
117496308
Device count
5
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
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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
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