FDA.reportPublic FDA data

BSXMED

Primary DI
06920485308450
Brand
BSXMED
Company
Shenzhen BSX Technology Electronics Co., Ltd.
Model
BSX253
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
K202324000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202324000Fingertip Pulse OximeterShenzhen Bsx Technology Electronics Co., Ltd.2020-12-14DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06920485308450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06920485308450069204853084506920485308450

GMDN Terms#

Term, Definition table
TermDefinition
Pulse Co-oximeterA portable, battery-powered, electronic device designed to detect hypoxia (oxygen deficiency at the tissue level) via the transcutaneous multiwave measurement and display of carboxy-haemoglobin saturation (SpCO) and typically other related parameters such as haemoglobin oxygen saturation (SpO2), methaemoglobin saturation (SpMet), and haemoglobin concentration (SpHb); pulse rate and haematocrit may also be calculated. A light-emitting diode (LED) and a receiving detector in a probe applied to a body site (e.g., a fingertip) are used to make multiwave measurements using spectrophotometry. The device is used in healthcare settings or the home, often to evaluate carbon monoxide poisoning.

Regulatory Flags#

DUNS number
551105453
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
true
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
06920485308580P PANACAREBSX3222026-08-26
06920485308542BSXBSX50112026-08-14
06920485308467BSXMEDBSX50352026-06-01
06920485308412PANACAREBSX3222026-05-23
06920485307743MOR CAREBSX3252025-10-15
06920485307804BSXBSX5232025-10-15
06920485307583BSXINBSX3152025-06-30
06920485305015BOTHEALTHBSX5012019-12-14
06920485305053BOTHEALTHBSX5052019-12-14
06920485305084BOTHEALTHBSX5082019-12-14
06920485305138BOTHEALTHBSX5132019-12-14
06920485305152BOTHEALTHBSX5152019-12-14
06920485305190BOTHEALTHBSX5192019-12-14
06920485305268BOTHEALTHBSX5262019-12-14
06920485305381BOTHEALTHBSX5382019-12-14
06920485305534BOTHEALTHBSX5532019-12-14
06920485305565BOTHEALTHBSX5562019-12-14
06920485305589BOTHEALTHBSX5582019-12-14
06920485305619BOTHEALTHBSX5612019-12-14
06920485305633BOTHEALTHBSX5632019-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20884838115389Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
20884838115396Nasal Alar SpO2 SensorPhilips Medizin Systeme Böblingen GmbHDQA2026-10-16
06946725572818APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572825APKAPK Technology Co.,Ltd.DQA2026-10-14
06946725572801APKAPK Technology Co.,Ltd.DQA2026-10-09
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQA2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQA2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQA2026-10-04
06924054300586BERRY®SHANGHAI BERRY ELECTRONIC TECH CO., LTD.DQA2026-04-22
06946725549926APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549933APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549940APKAPK Technology Co.,Ltd.DQA2026-03-19
06946725549919APKAPK Technology Co.,Ltd.DQA2026-03-17
06946725513606APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513613APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513620APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513637APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513644APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513651APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513668APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513675APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513682APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513699APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513705APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513712APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513729APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513736APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513743APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513750APKAPK Technology Co.,Ltd.DQA2026-03-10
06946725513767APKAPK Technology Co.,Ltd.DQA2026-03-10