FDA.reportPublic FDA data

Guardian Angel™ Rx

Primary DI
14719872650055
Brand
Guardian Angel™ Rx
Company
AULISA MEDICAL USA, INC.
Model
GA1000-A
Device description
Digital Vital Sign Monitoring System (with two Adult Oximeter Sensor Cables), RX ONLY
Published
2019-04-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162580000Guardian Angel GA1000 Digital Vital Sign Monitoring SystemTaiwan Aulisa Medical Devices Technologies, Inc.2017-03-03DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14719872650055PackageGS11Not in Commercial Distribution
04719872650058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471987265005514719872650055
04719872650058047198726500584719872650058

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116820893
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719872650034Guardian Angel™ RxGA1001Rx2019-11-27
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
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
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00093351041099N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013550N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
00845717013567N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06931973400563CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400730CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973400785CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410326CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410333CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
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06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09