BCI

GUDID 10610586039645

Smiths Medical ASD, Inc.

Pulse oximeter, line-powered
Primary Device ID10610586039645
NIH Device Record Keya51e2781-caa9-474c-85d8-0df5a7c19116
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model NumberWW1018B
Company DUNS082005361
Company NameSmiths Medical ASD, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110610586039645 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-13
Device Publish Date2019-12-05

On-Brand Devices [BCI]

10610586039676WW1018Y
10610586039645WW1018B
10610586039669WW1018R
10610586039652WW1018G
150195170430513419
150195170591993311

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