FDA.reportPublic FDA data

A9800 Anesthesia Workstation

Primary DI
00815085020139
Brand
A9800 Anesthesia Workstation
Company
ORICARE INC.
Model
A9800
Catalog number
0081508502013
Device description
Anesthesia Workstation with standard features only: English Language. USA 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
BSZGas-Machine, Anesthesia

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSZGas-Machine, AnesthesiaAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131790000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131790000A9800 ANESTHESIA WORKSTATIONOricare, Inc.2014-05-09BSZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815085020139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815085020139008150850201398150850201390815085020139

GMDN Terms#

Term, Definition table
TermDefinition
Anaesthesia workstation, general-purposeAn assembly of electronic devices used for general inhalation anaesthesia (i.e., the delivery of oxygen (O2), nitrous oxide (N2O), other medical gases, and anaesthetic agents) and possibly total intravenous anaesthesia and local anaesthesia. Its main components are high, intermediate, and low pressure gas delivery systems, a breathing circuit (typically with a ventilator), and an anaesthetic gas scavenging system (AGSS). It has built-in alarms, analysers, control/monitoring systems, and typically has integrated circuitry/touchscreen displays for target controlled anaesthesia (TCA) for any type of patient (e.g., neonate, adult).

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-10 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
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
00815085020214A9800 Anesthesia WorkstationA980000815085020212016-03-25

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