BCI

GUDID 30843418001099

SMITHS MEDICAL MD, INC.

Transportable physiologic monitoring system
Primary Device ID30843418001099
NIH Device Record Key08473b00-f0e8-412f-b87e-6c04b0f24304
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model NumberWW3078
Company DUNS106712748
Company NameSMITHS MEDICAL MD, 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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS130843418001099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQAOximeter

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-08-17
Device Publish Date2016-10-11

On-Brand Devices [BCI]

006950858002107204045
35019517062667WW1100
35019517062254WW8030
35019517062247WW1131
35019517062230WW1130
35019517062223WW1129
35019517062216WW1124
35019517062209124002
35019517062179124006
35019517054228WW1140
35019517054143WW3138
350195170539791153B
350195170539551149T
350195170539481140M
350195170539311140B
350195170539241102P
350195170538941101A
35019517053849125003
350195170537959189
350195170537408211
350195170537268044
350195170536963137
350195170536891300
350195170536721179
350195170536651163
350195170536581152
350195170536411148
350195170536341123
350195170536271128
350195170536101105
350195170425843135
350195170425773134
350195170425603049
30843418001280WW1021SYS
30843418001211WW1030P1EN
30843418001204WW1020P1EN
308434180011053301A4
30843418001099WW3078
308434180010823301A2
308434180008493301A1
30843418000818WW1026SYS
30843418000801WW1025SYS
30843418000757WW1028SYS
30843418000740WW1096SYS
30843418000375WW1020A1EN
30843418000283WW1000A1EN
30843418000191WW1030EN
30843418000108WW1020EN
30843418000016WW1000EN
30610586038444WW8214

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