FDA.reportPublic FDA data

VOCSN High Flow Kit

Primary DI
00850018761260
Brand
VOCSN High Flow Kit
Company
Ventec Life Systems, Inc.
Model
Pediatric High Flow Nasal Cannula Kit
Catalog number
PRT-01480-000
Device description
Pediatric High Flow Nasal Cannula Kit
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
CATCannula, Nasal, Oxygen
CBKVentilator, Continuous, Facility Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
CATCannula, Nasal, OxygenAnesthesiology1
CBKVentilator, Continuous, Facility UseAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850018761260PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850018761260008500187612608500187612600850018761260

GMDN Terms#

Term, Definition table
TermDefinition
Portable electric ventilatorA portable, electrically-powered device intended to provide long-term alveolar support for patients who do not require complex critical care ventilation. It typically uses positive pressure to deliver gas to the lungs at normal breathing rates and tidal volumes through invasive ventilation (i.e., with an artificial airway); it may also be used non-invasively (e.g., with a mask). It includes a control system and alarms, and may include a built-in humidifier. Several methods of cycling and ventilation modes may be used. It may be line and/or internal/external battery-powered for use in the home or a healthcare facility (including ambulatory).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure50 KiloPascal110 KiloPascal
Handling Environment Temperature-10 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078758082
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850018761048VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-00X2020-10-07
00850018761062VOCSN Patient Breathing PackageAdult, Active, Heated, Oxygen, BluePRT-00798-00X2020-10-07
00850018761116VOCSNV+C, JapanesePRT-01098-1XX2021-02-23
00855573007013VOCSN External Bacterial FilterPRT-00790-001PRT-00790-0032017-11-11
00855573007037VOCSN Patient Breathing PackageAdult, Active, Oxygen, BluePRT-00794-0012017-11-11
00855573007044VOCSN Patient Breathing PackageAdult, Passive, Oxygen, BluePRT-00793-0012017-11-11
00855573007075VOCSN Patient Breathing PackageAdult, Passive, BluePRT-00792-0012019-01-30
00855573007082VOCSN Patient Breathing PackageAdult, Active, Heated, BluePRT-00795-0012019-01-30
00855573007099VOCSN Patient Breathing Package Adult, Passive, Heated, BluePRT-00796-0012019-01-30
00855573007105VOCSN Nurse Call CableNormally ClosedPRT-00820-0012017-11-11
00855573007112VOCSN Nurse Call CableNormally OpenPRT-00821-0012017-11-11
00855573007129VOCSN Travel Suction CanisterPRT-00824-000PRT-00824-0012017-11-11
00855573007181VOCSN Patient Breathing PackagePediatric, Valveless, BluePRT-00927-0012019-01-30
00855573007228VOCSN Patient Breathing PackageAdult, Valveless, BluePRT-00926-0012019-01-30
00855573007235VOCSN Patient Breathing PackageAdult, Valveless, Heated, BluePRT-00928-0012019-01-30
00855573007341VOCSN Patient Breathing PackagePediatric, Valveless, Heated, BluePRT-00929-0012019-01-30
00855573007549VOCSN Patient Breathing PackagePediatric, Active, BluePRT-00799-0012018-07-10
00855573007563VOCSN Patient Breathing PackagePediatric, Active, Heated, BluePRT-00803-0012018-07-11
00855573007587VOCSN Patient Breathing PackagePediatric, Active, Oxygen, BluePRT-00802-0012018-07-11
00855573007600VOCSN Patient Breathing PackagePediatric, Active, Heated, Oxygen, BluePRT-00806-0012018-07-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
00198843006454LTVZoll Medical CorporationCBK2026-09-18
00198843006492LTVZoll Medical CorporationCBK2026-09-18
00198843006515LTVZoll Medical CorporationCBK2026-09-18
00198843006539LTVZoll Medical CorporationCBK2026-09-18
00198843007352LTVZoll Medical CorporationCBK2026-09-18
00848530108816Breathing CircuitSunset Healthcare Solutions, Inc.CBK2026-04-17
00848530106119Pediatric CannulaSunset Healthcare Solutions, Inc.CAT2025-05-21
00848530106126Infant CannulaSunset Healthcare Solutions, Inc.CAT2025-05-21
00848530104832Soft Adult CannulaSunset Healthcare Solutions, Inc.CAT2025-05-14
00789091681557Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00789091681571Adulat Soft CannulaSunset Healthcare Solutions, Inc.CAT2025-04-24
00848530090326CannulaSunset Healthcare Solutions, Inc.CAT2024-08-01
00848530097028CannulaSunset Healthcare Solutions, Inc.CAT2024-08-01
00848530097011CannulaSunset Healthcare Solutions, Inc.CAT2024-06-27
00848530096823CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530096830CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530096847CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530100759CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530100766CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530100773CannulaSunset Healthcare Solutions, Inc.CAT2024-06-22
00848530061197Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530103804Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104283Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104290Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104306Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104313Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104320Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104337Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15
00848530104344Oxygen KitSunset Healthcare Solutions, Inc.CAT2024-06-15