FDA.reportPublic FDA data

Alaris

Primary DI
10885403822018
Brand
Alaris
Company
CAREFUSION 303, INC.
Model
8220
Device description
Alaris SP02 Module Massimo
Published
2016-12-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K010966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K010966000MEDLEY SP02 MODULE, MODEL 8220Alaris Medical Systems, Inc.2001-06-08DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403822018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540382201810885403822018

GMDN Terms#

Term, Definition table
TermDefinition
Patient monitoring system module, pulse oximetryA small unit dedicated to the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in blood using light detection methods (spectrophotometry) after light is emitted from a light-emitting diode (LED) situated in the connected probe. It is designed to operate as part of a patient monitoring system enhancing the function of this system (the parent device). The module automatically plugs into the parent device when the user places it into a standardized slot in the parent device or a connected module rack. The parent device operates as a mainframe computer displaying the pulse oximetry parameters provided by this module.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Storage Environment Atmospheric Pressure 760 Low to 375 High mmHg
Storage Environment Humidity5 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-7825CustCareInfusion@carefusion.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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Primary DI, Brand, Company table
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06920485308450BSXMEDShenzhen BSX Technology Electronics Co., Ltd.DQA2026-06-01
10884521855397NellcorCovidien LPDQA2026-05-29
10884521855403NellcorCovidien LPDQA2026-05-29
B3944060056010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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B3945700048090WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048100WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700051020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700063010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700064010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700068020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
09551028900069Cables and SensorsXINMED SDN. BHD.DQA2026-04-22
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
08052990320318MIRMIR MEDICAL INTERNATIONAL RESEARCH SPADQA2026-04-03