FDA.reportPublic FDA data

acurio

Primary DI
06972382160211
Brand
acurio
Company
XIAMEN ACURIO INSTRUMENT CO.,LTD
Model
AS-301
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180685000AS-3XX Series Fingertip Pulse OximeterXiamen Acurio Instruments Co., Ltd.2018-11-29DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16972382160225PackageGS1100In Commercial Distribution
06972382160211PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697238216022516972382160225
06972382160211069723821602116972382160211

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeterAn electrically-powered photoelectric device designed for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals are produced by light-emitting diodes (LEDs) and received by a photodetector. The device displays the SpO2 values and may also measure/display pulse rate. It is typically applied to the fingertip or around the wrist, may be single-component (with built-in probe) or multi-component (includes external probe), and may in addition wirelessly transmit measurements to a receiving location (e.g., central station, bedside monitor); it is intended to be operated by laypersons and healthcare providers.

Regulatory Flags#

DUNS number
544491528
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972382160266acurioAS-3022022-05-25
16972382160256acurioAS-3022022-05-25
00810053630013SANTAMEDICALSM-ACLED1502020-06-01
06972382160068acurioAS-3022020-05-29
06972382160198SANTAMEDICALAS-301-L2020-06-02
06972382160235DR. SANAAS-302-L2020-10-22
10810053630010SANTAMEDICALSM-ACLED1502020-06-01
16972382160201SANTAMEDICALAS-301-L2020-06-02
16972382160249DR. SANAAS-302-L2020-10-22
16972382160225acurioAS-3012020-06-30
16972382160188acurioAS-3022020-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06972040113849N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
06972040113856N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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