ConFirm 24 Steam Biological Indicators CSBI25

GUDID 50732224000447

Self-Contained Biological Indicator, 24 hour incubation

SPS Medical Supply Corp.

Biological sterilization indicator
Primary Device ID50732224000447
NIH Device Record Keycacd0d99-25ec-437f-a62b-c682fe526910
Commercial Distribution StatusIn Commercial Distribution
Brand NameConFirm 24 Steam Biological Indicators
Version Model NumberCSBI25
Catalog NumberCSBI25
Company DUNS194877072
Company NameSPS Medical Supply Corp.
Device Count25
DM Exempttrue
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

Customer Support Contacts

Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com
Phone+1(585)359-0167
Emailregulatoryaffairs@hu-friedy.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature away from sterilants or other chemicals

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224000442 [Unit of Use]
GS110732224000449 [Primary]
GS150732224000447 [Package]
Contains: 10732224000449
Package: case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2023-08-18
Device Publish Date2023-08-10

Devices Manufactured by SPS Medical Supply Corp.

10732224720132 - SporView SELF-CONTAINED EO GAS BI2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
10732224720149 - SporView SELF-CONTAINED EO GAS BI2024-03-19 In-office biological indicators for use in monitoring the efficacy of EO Gas processes.
50732224720017 - PASSPORT MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720024 - PASSPORT MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720031 - PassPort MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720048 - PassPort MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720796 - PASSPORT PLUS MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.
50732224720802 - PASSPORT PLUS MAIL-IN SYSTEM2023-10-09 Mail-in spore strips for use in monitoring the efficacy of Steam, Chemical Vapor, Dry Heat and EO Gas processes.

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