FDA.reportPublic FDA data

Belun Ring

Primary DI
04899959015083
Brand
Belun Ring
Company
Belun Technology Company Limited
Model
BLR-100X
Device description
Belun Ring BLR-100X Size M
Published
2022-04-13
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
K211407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211407000Belun Ring BLR-100XBelun Technology Company Limited2021-10-21DQA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04899959015083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04899959015083048999590150834899959015083

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
664437924
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04897140630114Belun RingBLR-100X2025-11-13
04899959015007Belun RingBLR-100X2023-12-05
04899959015076Belun RingBLR-100X2022-04-13
04899959015090Belun RingBLR-100X2022-04-13
04899959015014Belun RingBLR-100C2020-12-31
04899959015021Belun RingBLR-100C2020-12-31
04899959015038Belun RingBLR-100C2020-12-31
04899959015045Belun RingBLR-100C2020-12-31
04899959015052Belun RingBLR-100C2020-12-31
04899959015069Belun RingBLR-100C2020-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00010939962218N/AShenzhen AOJ Medical Technology Co., LtdDQA2026-07-11
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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
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06931973410746CaremedShenzhen Caremed Medical Technology Co., Ltd.DQA2026-07-09