BCI

GUDID 10610586039676

Smiths Medical ASD, Inc.

Pulse oximeter, line-powered
Primary Device ID10610586039676
NIH Device Record Key90dfdd9f-5403-465d-bc83-1e72d89fef47
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model NumberWW1018Y
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
GS110610586039676 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DPZOximeter, ear

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.