FDA.reportPublic FDA data

V8800 Critical Care Ventilator

Primary DI
00815085020283
Brand
V8800 Critical Care Ventilator
Company
ORICARE INC.
Model
V8800
Catalog number
0081508502028
Device description
Critical Care Ventilator with standard features Plus: Carbon Dioxide Monitor. German Language. Europe 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
00815085020283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815085020283008150850202838150850202830815085020283

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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