Owren's Veronal Buffer

GUDID M52553750

HELENA LABORATORIES CORPORATION

Buffered sample diluent IVD
Primary Device IDM52553750
NIH Device Record Key79caa4ea-af26-4712-957c-cfcc8e7d4772
Commercial Distribution StatusIn Commercial Distribution
Brand NameOwren's Veronal Buffer
Version Model Number5375
Company DUNS079396131
Company NameHELENA LABORATORIES CORPORATION
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM52553750 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JPASYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-06-02
Device Publish Date2016-09-07