FDA.reportPublic FDA data

VOCSN Patient Breathing Package

Primary DI
00855573007341
Brand
VOCSN Patient Breathing Package
Company
Ventec Life Systems, Inc.
Model
Pediatric, Valveless, Heated, Blue
Catalog number
PRT-00929-001
Device description
VOCSN Patient Breathing Package (Pediatric, Valveless, Heated, Blue)
Published
2019-01-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Product Codes#

Code, Name table
CodeName
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
CBKVentilator, Continuous, Facility Use
NHJDevice, Positive Pressure Breathing, Intermittent
NOUContinuous, Ventilator, Home Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2
CBKVentilator, Continuous, Facility UseAnesthesiology2
NHJDevice, Positive Pressure Breathing, IntermittentAnesthesiology2
NOUContinuous, Ventilator, Home UseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162877000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162877000VOCSN Unified Respiratory SystemVentec Life Systems, Inc.2017-04-07CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00855573007358PackageGS110In Commercial Distribution
00855573007341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00855573007358008555730073588555730073580855573007358
00855573007341008555730073418555730073410855573007341

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).

Regulatory Flags#

DUNS number
078758082
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
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
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
00855573007624VOCSN Patient Breathing PackagePediatric, Passive, BluePRT-00800-0012018-07-11

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