FDA.reportPublic FDA data

Alaris

Primary DI
10885403830020
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8300
Device description
Alaris EtCO2 Module
Published
2021-10-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
FRNPump, infusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2
FRNPump, InfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072105000
K211218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072105000ALARIS SYSTEM WITH MMS, MODEL 8XXXCardinal Health 303,Inc.2007-12-28FRN
K211218000BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.2023-07-21FRN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403830020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540383002010885403830020

GMDN Terms#

Term, Definition table
TermDefinition
Carbon dioxide monitorA mains electricity (AC-powered) device intended to continuously measure the concentration of carbon dioxide (CO2) in a gas mixture through a particular method (e.g., electrochemical, infrared absorption, gas chromatographic, mass spectrometric) to determine a patient's ventilatory, circulatory, or metabolic status. It is typically used to measure end-tidal carbon dioxide (EtCO2) in expiratory gases during the administration of anaesthesia or during bedside monitoring. Commonly known as a capnograph or a capnometer, the sampling method can be "mainstream" and/or "sidestream".

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal101 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)237-2762ProductComplaints@bd.com
+1(844)823-5433ProductComplaints@bd.com

Regulatory Flags#

DUNS number
360624720
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885403477829Pyxis3383382018-10-15
10885403533228BD Pyxis3233232025-11-14
10885403533235BD Pyxis3243242025-11-14
10885403533242Pyxis3273272025-11-14
10885403521836Pyxis Pro MedStation177-216177-2162025-08-01
10885403521966Pyxis Pro MedStationSW-MS-ES-PRO-V48SW-MS-ES-PRO-V482025-08-01
10885403521935Pyxis MedStationSW-MS-ES-V48SW-MS-ES-V482025-07-23
10885403517822Pyxis Pro MedStation1149-001149-002025-06-05
10885403517839Pyxis Pro MedStation1152-001152-002025-06-05
10885403521300Pyxis Pro MedStation1155-001155-002025-06-05
10885403518348BD Pyxis™SW-SVR-ES-551115-002024-12-06
10885403520327BD Pyxis™SW-MS-ES-V47SW-MS-ES-V472024-12-06
10885403520341BD Pyxis™SW-SVR-ES-57SW-SVR-ES-572024-12-06
10885403517167BD Pyxis1145-001145-002023-09-29
10885403517174BD Pyxis1146-001146-002023-09-29
10885403517181BD Pyxis1147-001147-002023-09-29
10885403517198BD Pyxis1148-001148-002023-09-29
10885403513749BD PyxisSW-MS-4000-V7SW-MS-4000-V72022-12-02
10885403513756BD PyxisSW-MS-ES-V4SW-MS-ES-V42022-12-02
10885403513770BD PyxisSW-PAS-ES-V2SW-PAS-ES-V22022-12-02

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