BCI

GUDID 15019517043082

SMITHS MEDICAL MD, INC.

Peripheral vascular infusion catheter
Primary Device ID15019517043082
NIH Device Record Key884ed477-040e-4667-bdf9-d25c226e3c57
Commercial Distribution StatusIn Commercial Distribution
Brand NameBCI
Version Model Number6124
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 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
GS115019517043082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-09
Device Publish Date2016-10-13

On-Brand Devices [BCI]

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30843418000283WW1000A1EN
30843418000191WW1030EN
30843418000108WW1020EN
30843418000016WW1000EN
30610586038444WW8214

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