FDA.reportPublic FDA data

V8800 Critical Care Ventilator

Primary DI
00815085020344
Brand
V8800 Critical Care Ventilator
Company
ORICARE INC.
Model
V8800
Device description
Critical Care Ventilator with standard features: Chinese Language. China Power Setup
Published
2016-03-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTICompressor, Air, Portable
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
CBKVentilator, Continuous, Facility Use
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTICompressor, Air, PortableAnesthesiology2
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2
CBKVentilator, Continuous, Facility UseAnesthesiology2
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120931000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120931000CRITICAL CARE VENTILATOROricare, Inc.2013-06-06CBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815085020344PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815085020344008150850203448150850203440815085020344

GMDN Terms#

Term, Definition table
TermDefinition
Neonatal/adult intensive-care ventilatorA mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-215-538-2470Suzy@Oricaremed.com

Regulatory Flags#

DUNS number
009527042
Device count
1
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815085020016A9800 Anesthesia WorkstationA980000815085020012016-03-25
00815085020023A9800 Anesthesia WorkstationA980000815085020022016-03-25
00815085020030A9800 Anesthesia WorkstationA980000815085020032016-03-25
00815085020047A9800 Anesthesia WorkstationA980000815085020042016-03-25
00815085020054A9800 Anesthesia WorkstationA980000815085020052016-03-25
00815085020061A9800 Anesthesia WorkstationA980000815085020062016-03-25
00815085020078A9800 Anesthesia WorkstationA980000815085020072016-03-25
00815085020085A9800 Anesthesia WorkstationA980000815085020082016-03-25
00815085020092A9800 Anesthesia WorkstationA980000815085020092016-03-25
00815085020108A9800 Anesthesia WorkstationA980000815085020102016-03-25
00815085020115A9800 Anesthesia WorkstationA980000815085020112016-03-25
00815085020122A9800 Anesthesia WorkstationA980000815085020122016-03-25
00815085020139A9800 Anesthesia WorkstationA980000815085020132016-03-25
00815085020146A9800 Anesthesia WorkstationA980000815085020142016-03-25
00815085020153A9800 Anesthesia WorkstationA980000815085020152016-03-25
00815085020160A9800 Anesthesia WorkstationA980000815085020162016-03-25
00815085020177A9800 Anesthesia WorkstationA980000815085020172016-03-25
00815085020184A9800 Anesthesia WorkstationA980000815085020182016-03-25
00815085020191A9800 Anesthesia WorkstationA980000815085020192016-03-25
00815085020207A9800 Anesthesia WorkstationA980000815085020202016-03-25

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