H-Pette without Blade (1000 pieces)

GUDID M52536110

HELENA LABORATORIES CORPORATION

Blood specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD Blood/blood culture specimen transfer spike IVD
Primary Device IDM52536110
NIH Device Record Keyd415740a-05f4-4ee1-a728-67952377e84b
Commercial Distribution StatusIn Commercial Distribution
Brand NameH-Pette without Blade (1000 pieces)
Version Model Number3611
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com
Phone1-800-231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM52536110 [Primary]

FDA Product Code

GJGPipette, Quantitative, Hematology

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-01-22
Device Publish Date2017-05-26

Devices Manufactured by HELENA LABORATORIES CORPORATION

M52518360 - V8 Urine Preparation Buffer2023-09-18
M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit2023-09-18
M52510680010 - SPIFE Touch, CSA 2015 (120V)2023-09-11
M52510690000 - SPIFE Touch (230V)2023-09-11
M52510880010 - SPIFE 3000 w/ New Pump & Valve (110V)2023-09-11
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.