B200 SERIES

GUDID B2001004N03

B200 SERIES PULSE OXIMETER

BETA BIOMED SERVICES INC

Pulse oximeter, line-powered
Primary Device IDB2001004N03
NIH Device Record Keydab19a03-745b-47a1-ba34-9edcebf097f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameB200 SERIES
Version Model NumberB200-1004N
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
HIBCCB2001004N01 [Primary]
HIBCCB2001004N03 [Package]
Contains: B2001004N01
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 Date2017-03-08

On-Brand Devices [B200 SERIES]

B2001017B200 SERIES EAR PULSE OXIMETER SENSOR
B2001011M03B200 SERIES PULSE OXIMETER SENSOR
B2001004N03B200 SERIES PULSE OXIMETER

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