FDA.report

Belun Ring

Primary DI
04899959015045
Brand
Belun Ring
Company
Belun Technology Company Limited
Model
BLR-100C
Device description
Belun Ring Size 10
Published
2020-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQAOximeter

Product Code Classifications

CodeDeviceSpecialtyClass
DQAOximeterCardiovascular2

Premarket Submissions

SubmissionSupplement
K191417000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K191417000Belun RingBelun Technology Company Limited2019-10-10DQA

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04899959015045PrimaryGS10

GMDN Terms

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

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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04897140630114Belun RingBLR-100X2025-11-13
04899959015007Belun RingBLR-100X2023-12-05
04899959015076Belun RingBLR-100X2022-04-13
04899959015083Belun RingBLR-100X2022-04-13
04899959015090Belun RingBLR-100X2022-04-13
04899959015014Belun RingBLR-100C2020-12-31
04899959015021Belun RingBLR-100C2020-12-31
04899959015038Belun RingBLR-100C2020-12-31
04899959015052Belun RingBLR-100C2020-12-31
04899959015069Belun RingBLR-100C2020-12-31

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