Getinge Assured AccuView Biological Test Pack with 25 Controls 61301606715

GUDID 10814434020735

STERITEC PRODUCT MFG. CO., INC.

Biological sterilization indicator
Primary Device ID10814434020735
NIH Device Record Key4bfcbe81-27ad-43f9-8260-d72a979a325b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Assured AccuView Biological Test Pack with 25 Controls
Version Model Number61301606715
Catalog Number61301606715
Company DUNS622223196
Company NameSTERITEC PRODUCT MFG. CO., INC.
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 Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 70 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS100814434020738 [Primary]
GS110814434020735 [Package]
Contains: 00814434020738
Package: Case [25 Units]
In Commercial Distribution

FDA Product Code

FRCIndicator, Biological Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-26
Device Publish Date2018-09-25

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