STA® - Quality HNF/UFH

GUDID 03607450003819

DIAGNOSTICA STAGO

Heparin anti-Xa IVD, control
Primary Device ID03607450003819
NIH Device Record Key73390d5a-dcaa-48ee-99e9-079ec250852e
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTA® - Quality HNF/UFH
Version Model Number00381
Company DUNS262277122
Company NameDIAGNOSTICA STAGO
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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 Perscriptiontrue
OTC Over-The-Counterfalse

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

Device Identifiers

Device Issuing AgencyDevice ID
GS103607450003819 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GGNPLASMA, COAGULATION CONTROL

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-23
Device Publish Date2016-09-15

Devices Manufactured by DIAGNOSTICA STAGO

03607450581041 - STA Satellite®2022-09-16
03607450589788 - STA-R Evolution® Expert Series2022-09-16
03607450589795 - STA-R Evolution® Expert Series (with cap piercing option)2022-09-16
03607450589894 - STA Compact Max® (with cap piercing option)2022-09-16
03607450589900 - STA Compact Max®2022-09-16
03607450590104 - STA R Max® (with cap piercing option)2022-09-16
03607450590135 - STA R Max®2022-09-16
03607450590265 - STA R Max®2022-09-16

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