Catalog Number

448803

Brand Name

BD Phoenix™ SMIC-101

Version/Model Number

448803

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K050745,K050747,K050780,K050865,K050881,K050946,K050982,K051109,K051138,K051204,K051266,K051272,K051692,K062206,K050745,K050747,K050780,K050865,K050881,K050946,K050982,K051109,K051138,K051204,K051266,K051272,K051692,K062206

Product Code

LON

Product Code Name

SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Public Device Record Key

fd3a0566-f671-4d56-ad32-b6bb161afd3d

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

May 19, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-