FDA.reportPublic FDA data

N/A

Primary DI
06972040110473
Brand
N/A
Company
Shenzhen AOJ Medical Technology Co., Ltd
Model
AOJ-70E
Published
2021-01-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQAOximeter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202173000Pulse OximeterShenzhen AOJ Medical Technology Co., Ltd.2020-12-07DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972040110473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972040110473069720401104736972040110473

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, battery-poweredA portable, battery-powered, photoelectric device intended for the transcutaneous measurement and display of haemoglobin oxygen saturation (SpO2). The signals, typically produced by light-emitting diodes (LEDs) and a receiving detector in a probe, or directly built-in, are used to make the measurements using the principle of spectrophotometry. The oximeter displays the SpO2 values and may calculate/display other parameters, e.g., pulse rate, electrocardiogram (ECG). The device is typically applied to the fingertip or around the wrist; it may be used by healthcare facilities, emergency services, or in the home.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554409093
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972040117540N/AAOJ-F1062026-03-26
06972040117557N/AAOJ-F1072026-03-26
06972040110800N/AAOJ-35A2026-03-25
06972040110978N/AAOJ-35G2026-03-25
06972040111029N/AAOJ-F1022026-03-25
06972040111296N/AAOJ-35F2026-03-25
06972040111418N/AARM-30H2026-03-25
06972040111494N/AARM-30J2026-03-25
06972040111654N/AWRS-35H2026-03-25
06972040112002N/AARM-30K2026-03-25
06972040112019N/AARM-90B2026-03-25
06972040112026N/AWRS-35K2026-03-25
06972040112033N/AWRS-35N2026-03-25
06972040112071N/AAOJ-F1012026-03-25
06972040112088N/AAOJ-F1032026-03-25
06972040112590N/AWRS-35S2026-03-25
06972040113801N/AWRS-35P2026-03-25
06972040117526N/AAOJ-F1042026-03-25
06972040117533N/AAOJ-F1052026-03-25
06972040110572N/AAOJ-35B2021-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06931973410340CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410364CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410371CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410388CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410395CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410401CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410418CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410425CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410432CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410449CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410456CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410647CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410678CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410685CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410692CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410715CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410722CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410739CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410753CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410760CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410777CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410784CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410791CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09
06931973410807CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09