FDA.report

Belun Ring

Primary DI
04899959015083
Company
Belun Technology Company Limited
Model
BLR-100X
Device description
Belun Ring BLR-100X Size M
Published
2022-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Regulatory Flags

DUNS number
664437924
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
04899959015083PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
04899959015083PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQAOximeter2Cardiovascular870.2700NEligible

Premarket Submissions

SubmissionSupplement
K211407000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K211407000Belun Ring BLR-100XBelun Technology Company Limited2021-10-21DQA

GMDN Terms

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

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

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