FDA.reportPublic FDA data

B500 SERIES

Primary DI
B5011011M01
Brand
B500 SERIES
Company
BETA BIOMED SERVICES INC
Model
B501-1011M
Device description
B500 SERIES PULSE OXIMETER SENSOR
Published
2017-05-05
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B5011011M03PackageHIBCC1In Commercial Distribution
B5011011M01PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Pulse oximeter, line-poweredA mains electricity (AC-powered) photoelectric device intended for the continuous 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 used bedside.

Regulatory Flags#

DUNS number
959702788
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B4001006AV1002B400 SERIESB400-1006AV-102023-06-08
B4001006AV402B400 SERIESB400-1006AV-42023-06-08
B4001006AV02B400 SERIES B400-1006AV2023-06-08
B4001006AV1003B400 SERIESB400-1006AV-102023-06-08
B4001006AV403B400 SERIESB400-1006AV-42023-06-08
B5051002N10B500 SERIESB505-1002N-102019-03-14
B5051002N103B500 SERIESB505-1002N-102019-03-14
B1001011B100 SERIESB100-10112017-05-05
B2001004N01B200 SERIESB200-1004N2017-03-08
B2001011M01B200 SERIESB200-1011M2017-01-26
B2001016B200B200-10162017-08-31
B3001001B300 SERIES b300-10012017-09-15
B5011005B500 SERIESB501-10052017-09-15
B5051011M01B500 SERIESB505-1011M2017-05-05
B5051011M10B500 SERIESB505-1011M-102017-08-31
B5051011N01B500 SERIESB505-1011N2017-01-26
B5051017B500 SERIESB505-10172017-09-15
B5051033B01B500 SERIESB505-1033B2017-09-15
B5100602B500 SERIESB510-06022017-09-15
B100101103B100 SERIESB100-10112017-05-05

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Primary DI, Brand, Company table
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