FDA.reportPublic FDA data

Ventlab

Primary DI
10889483093887
Brand
Ventlab
Company
VENTLAB, LLC
Model
CS4001S
Device description
Medium Nasal CPAP Kit w/ Soft Headgear 10/cs
Published
2016-10-02
Public version status
Update
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
BZDVentilator, Non-Continuous (Respirator)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZDVentilator, Non-Continuous (Respirator)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040726000VENTLAB NASAL CPAP CANNULAVentlab Corp.2004-06-03BZD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483093884PackageGS110In Commercial Distribution
10889483093887PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948309388420889483093884
1088948309388710889483093887

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia breathing circuit, single-useAn assembly of devices designed to conduct medical gases from an anaesthesia unit/workstation to a patient artificial airway/anaesthesia mask (not included) during general anaesthesia. It includes breathing tubes and a Y-piece connector, typically with a ventilator/ventilation bag and appropriate connectors, and may include a carbon dioxide (CO2) absorber, a one-way directional valve, or adjustable pressure limiting (APL) valve. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00General Warehouse. Do not get wet.

Contacts#

Phone, Email table
PhoneEmail
800-433-2797info@sun-med.com

Regulatory Flags#

DUNS number
038305402
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483653371AirlifeAF3140MC-PWAF3140MC-PW2026-10-15
10889483654286AirlifeAF5040MBM52026-10-15
10889483654293AirlifeAF5140MBM52026-10-15
10889483654309AirlifeAF5140MBPM52026-10-15
10889483654316AirlifeAF5140MB-PWM52026-10-15
10889483097434VentlabSC2002016-09-26
10889483099261Ventlabbt60032016-10-01
10889483111185VentlabVS0600-CVS0600-C2023-07-12
10889483083758VentlabAF5140MB-F2016-11-16
10889483300732VentlabBR2002016-09-29
10889483300749VentlabBR200-502016-09-29
10889483300756VentlabBR2102016-09-29
10889483300787Ventlabbr3002016-09-30
10889483300794VentlabBR300-502016-09-30
10889483300800VentlabBR310BR3102016-10-01
10889483300817VentlabBR320BR3202016-10-01
10889483300824VentlabBR330BR3302016-10-01
10889483481226Ventlab Hyperinflation SystemHS4051-W2026-06-24
10889483227046VentlabR500P21R500P212023-07-18
10889483227022VentlabR500P30R500P302023-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06948538347683Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347690Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347706Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347713Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347720Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347737Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347744Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347751Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347768Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347775Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347782Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347799Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347805Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347812Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347829Alto Nasal Pillows InterfaceBMC Medical Co., Ltd.BZD2026-10-15
06948538347836Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347843Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347850Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347867Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347874Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347881Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347898Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347904Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347911Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347928Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347935Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347942Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347959Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347966Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15
06948538347973Alto Full Face MaskBMC Medical Co., Ltd.BZD2026-10-15