Qstat Control Level 1

GUDID 00850003761336

For Use with the QUANTRA® Hemostasis Analyzer

HEMOSONICS, LLC

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Primary Device ID00850003761336
NIH Device Record Keyddfb91f4-a23c-4113-8209-48392d3ceea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameQstat Control Level 1
Version Model NumberQStat Control Level 1 Kit (Box of 4)
Company DUNS193921041
Company NameHEMOSONICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com
Phone+1(800)280-5589
Emailsupport@hemosonics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100850003761336 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-03-08
Device Publish Date2024-02-29

Devices Manufactured by HEMOSONICS, LLC

00850003761336 - Qstat Control Level 12024-03-08For Use with the QUANTRA® Hemostasis Analyzer
00850003761336 - Qstat Control Level 12024-03-08 For Use with the QUANTRA® Hemostasis Analyzer
00850003761398 - Qstat Control Level 22024-03-08 For Use with the QUANTRA® Hemostasis Analyzer
00850003761183 - QStat Cartridge2024-03-08 For Use with the QUANTRA® Hemostasis Analyzer
00850003761107 - Quantra QPlus System2021-02-19 Quantra Desktop Remote Viewer
00850003761213 - Quantra QPlus System2021-02-19 QPlus Control Level 1 Kit
00850003761275 - Quantra QPlus System2021-02-19 QPlus Control Level 2 Kit
00850003761046 - Quantra QPlus System2020-10-06 Quantra Cleaning Cartridge
00850003761039 - Qunatra QPlus System2019-05-02 Quantra Hemostasis Analyzer
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