FDA.reportPublic FDA data

Guardian Angel™ Rx

Primary DI
04719872650072
Brand
Guardian Angel™ Rx
Company
AULISA MEDICAL USA, INC.
Model
GA-RS0002
Device description
Adult Oximeter Sensor Cable
Published
2019-04-13
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
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
04719872650072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719872650072047198726500724719872650072

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter probe, reusableA photoelectric device applied externally to a body site, e.g., a fingertip, ear lobe, the bridge of nose, a toe, or the bridge of the foot of a paediatric or adult patient for the transcutaneous measurement of haemoglobin oxygen saturation (SpO2) in arterial blood using light detection. The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector, are received by an oximeter to which this device is connected. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., electrocardiogram (ECG). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

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
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
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