Getinge Self-Contained BI Steam Vial Box

GUDID 00732224757490

Self-Contained BI Steam Vial Box

SPS Medical Supply Corp.

Biological sterilization indicator
Primary Device ID00732224757490
NIH Device Record Key8adac0cc-af16-4364-89de-40289290a9b5
Commercial Distribution StatusIn Commercial Distribution
Brand NameGetinge Self-Contained BI Steam Vial Box
Version Model Number6005500522
Company DUNS194877072
Company NameSPS Medical Supply Corp.
Device Count100
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-Countertrue

Customer Support Contacts

Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com
Phone+1(631)633-6201
Emailrcelestin@crosstex.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE
Special Storage Condition, SpecifyBetween 0 and 0 *TRUE

Device Identifiers

Device Issuing AgencyDevice ID
GS100732224757490 [Unit of Use]
GS110732224757497 [Primary]

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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-06-26
Device Publish Date2020-11-18

Devices Manufactured by SPS Medical Supply Corp.

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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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