V8 Maintenance Buffer Kit

GUDID M52518320

HELENA LABORATORIES CORPORATION

Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD Buffered wash solution IVD
Primary Device IDM52518320
NIH Device Record Keydbd47e93-5f8a-4336-b8f5-b3947cfff8c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameV8 Maintenance Buffer Kit
Version Model Number1832
Company DUNS079396131
Company NameHELENA LABORATORIES CORPORATION
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 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
HIBCCM52518320 [Primary]

FDA Product Code

CEFELECTROPHORETIC, PROTEIN FRACTIONATION

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2023-06-02
Device Publish Date2017-03-17

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M52510880020 - SPIFE 3000, "CE 2011" (120V)2023-09-11
M52510890010 - SPIFE 3000 w/ New Pump & Valve (220V)2023-09-11
M52510890020 - SPIFE 3000, "CE 2011" (230V)2023-09-11

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