FDA.reportPublic FDA data

Oxygen Tubing with Connector, 7ft

Primary DI
00850057117455
Brand
Oxygen Tubing with Connector, 7ft
Company
CORVENT MEDICAL, INC
Model
Oxygen Tubing with Connector, 7ft
Catalog number
91-101-US213
Published
2026-01-06
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
00850057117455PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850057117455008500571174558500571174550850057117455

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration tubingA length of flexible noninvasive tube, typically a small bore, thick-walled, anti-kink tubing (to prevent blockage) intended for the delivery of a pure oxygen (O2), or an O2 enriched gas, to a mask or nasal cannula (not included), during delivery of dry O2 to the patient. The tubing is typically available in standard coil lengths and is cut by clinical staff to appropriate lengths to create an extension or connecting piece. 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
1
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
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
00850057117196HME FiltersHME Filters91-101-US3062025-06-05

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