Tyvek Self Seal Pouch 12326

GUDID 20705037015723

Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 260 mm

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

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Primary Device ID20705037015723
NIH Device Record Key93bf8716-913b-4639-9fdd-f3b749e42c3b
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyvek Self Seal Pouch
Version Model Number12326
Catalog Number12326
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES INC.
Device Count250
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 Datetrue
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(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
Emailcomplaints@aspus.jnj.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com
Phone+1(888)783-7723
EmailASP-Complaints@asp.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110705037015726 [Primary]
GS120705037015723 [Package]
Contains: 10705037015726
Package: Case [2 Units]
In Commercial Distribution
GS180705037015725 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRGWrap, sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-08
Device Publish Date2016-09-24

On-Brand Devices [Tyvek Self Seal Pouch]

20705037015785Tyvek Self Seal Pouch with Sterrad Chemical Indicator 320 mm x 560 mm
20705037015778Tyvek Self Seal Pouch with Sterrad Chemical Indicator 250 mm x 480 mm
20705037015761Tyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 420 mm
20705037015754Tyvek Self Seal Pouch with Sterrad Chemical Indicator 200 mm x 400 mm
20705037015747Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 350 mm
20705037015730Tyvek Self Seal Pouch with Sterrad Chemical Indicator 150 mm x 320 mm
20705037015723Tyvek Self Seal Pouch with Sterrad Chemical Indicator 100 mm x 260 mm
20705037015716Tyvek Self Seal Pouch with Sterrad Chemical Indicator 75 mm x 200 mm
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