FDA.reportPublic FDA data

B100 SERIES

Primary DI
B100101103
Brand
B100 SERIES
Company
BETA BIOMED SERVICES INC
Model
B100-1011
Device description
B100 SERIES PULSE OXIMETER SENSOR
Published
2017-05-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
B100101103PackageHIBCC1In Commercial Distribution
B1001011PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
959702788
Device count
1
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

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
B5011011M01B500 SERIES B501-1011M2017-05-05
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

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Primary DI, Brand, Company table
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