B300 SERIES

GUDID B300100103

B300 SERIES PULSE OXIMETER SENSOR

BETA BIOMED SERVICES INC

Pulse oximeter, line-powered
Primary Device IDB300100103
NIH Device Record Key6c3dd35a-22fb-41d9-b49c-370eb20b0944
Commercial Distribution StatusIn Commercial Distribution
Brand NameB300 SERIES
Version Model Numberb300-1001
Company DUNS959702788
Company NameBETA BIOMED SERVICES INC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3001001 [Primary]
HIBCCB300100103 [Package]
Contains: B3001001
Package: BOX [1 Units]
In Commercial Distribution

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-09-15

Devices Manufactured by BETA BIOMED SERVICES INC

B4001006AV02 - B400 SERIES 2023-06-16 B400 SERIES ADAPTER / EXTENSION CABLE
B4001006AV1003 - B400 SERIES2023-06-16 B400 SERIES ADAPTOR / EXTENSION CABLES
B4001006AV403 - B400 SERIES2023-06-16 B400 SERIES ADAPTER / EXTENSION CABLE
B5051002N103 - B500 SERIES2019-03-22 B500 SERIES PULSE OXIMETER SENSOR
B100101103 - B100 SERIES2018-03-29 B100 SERIES PULSE OXIMETER SENSOR
B2001004N03 - B200 SERIES2018-03-29 B200 SERIES PULSE OXIMETER
B2001011M03 - B200 SERIES2018-03-29 B200 SERIES PULSE OXIMETER SENSOR
B200101603 - B2002018-03-29 B200 SERIES PULSE OXIMETER SENSOR

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.