Rowley Biochemical Bouin's Fluid SO-306

GUDID SO306852042008

Bouin's Fluid

TRANSENE COMPANY, INC.

Bouin's solution IVD
Primary Device IDSO306852042008
NIH Device Record Key1e99e50d-738a-4c0e-81c3-32bb53cef818
Commercial Distribution StatusIn Commercial Distribution
Brand NameRowley Biochemical Bouin's Fluid
Version Model Number1
Catalog NumberSO-306
Company DUNS044815983
Company NameTRANSENE COMPANY, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Dimensions

Total Volume4 Fluid Ounce

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCSO306852042008 [Primary]

FDA Product Code

IGNFluid, Bouin'S

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-23
Device Publish Date2019-09-13