FDA.reportPublic FDA data

Guardian Angel™ Rx

Primary DI
04719872650034
Brand
Guardian Angel™ Rx
Company
AULISA MEDICAL USA, INC.
Model
GA1001Rx
Device description
Digital Vital Sign Monitoring System (with Infant Oximeter Module), RX ONLY
Published
2019-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182822000Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.2019-03-01DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719872650031PackageGS11In Commercial Distribution
04719872650034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987265003114719872650031
04719872650034047198726500344719872650034

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximetry telemetric monitoring systemAn assembly of devices designed to continuously measure and wirelessly transmit haemoglobin oxygen saturation (SpO2) signals from a patient to a receiving location (e.g., central station, bedside monitor) for viewing. It typically consists of a portable transmitter with antenna and attached sensors (e.g., leads and electrodes) that are connected to the patient, as well as a receiver typically incorporated into a central station or bedside monitor that receives, consolidates, and displays the information. The system is typically used for ambulatory patients who require continuous monitoring (e.g., patients in step-down care areas).

Regulatory Flags#

DUNS number
116820893
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872650058Guardian Angel™ RxGA1000-A2019-04-13
04719872650065Guardian Angel™ Rx GA1000-P2019-04-13
04719872650096Guardian Angel™ Rx GA1000Rx-A2019-06-03
04719872650102Guardian Angel™ RxGA1000Rx-P2019-06-03
04719872650195Guardian Angel™ RxGA2000Rx-A2019-08-07
04719872650201Guardian Angel™ RxGA2000Rx-P2019-08-07
04719872650287Guardian Angel™ RxGA2001Rx2019-11-27
14719872650192Guardian Angel™ RxGA2000Rx-A2019-08-07
14719872650208Guardian Angel™ RxGA2000Rx-P2019-08-07
04719872650072Guardian Angel™ RxGA-RS00022019-04-13
04719872650089Guardian Angel™ RxGA-RS00042019-04-13
14719872650055Guardian Angel™ RxGA1000-A2019-04-13
14719872650062Guardian Angel™ Rx GA1000-P2019-04-13
14719872650031Guardian Angel™ RxGA1001Rx2019-11-27
14719872650284Guardian Angel™ RxGA2001Rx2019-11-27
14719872650093Guardian Angel™ Rx GA1000Rx-A2019-06-03
14719872650109Guardian Angel™ RxGA1000Rx-P2019-06-03
04719872650010Guardian Angel™ RxGA10002018-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06924054300623BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-06-04
06931973410890CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-06-02
08720256776567Corsano CardioWatch 287-2 SystemCorsano Health B.V.DQA2026-06-02
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
B3944670047010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945000030010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300046010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945300054020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945600013020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048010WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048020WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048030WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048040WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048050WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048060WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048070WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
B3945700048080WVSM Pro, Wireless Vital Signs Monitor ProfessionalATHENA GTX, INC.DQA2026-05-27
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