Tyvek Roll 12425

GUDID 20705037015839

Tyvek Roll with Sterrad Chemical Indicator 250 mm x 70 m

ADVANCED STERILIZATION PRODUCTS SERVICES INC.

Chemical/physical sterilization process indicator
Primary Device ID20705037015839
NIH Device Record Key16c9329c-c057-4835-92cd-10fa0b14223d
Commercial Distribution StatusIn Commercial Distribution
Brand NameTyvek Roll
Version Model Number12425
Catalog Number12425
Company DUNS947451626
Company NameADVANCED STERILIZATION PRODUCTS SERVICES 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-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
GS110705037015832 [Primary]
GS120705037015839 [Package]
Contains: 10705037015832
Package: Case [4 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JOJIndicator, physical/chemical sterilization process

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 Roll]

20705037015860Tyvek Roll with Sterrad Chemical Indicator 500 mm x 70 m
20705037015853Tyvek Roll with Sterrad Chemical Indicator 420 mm x 70 m
20705037015846Tyvek Roll with Sterrad Chemical Indicator 350 mm x 70 m
20705037015839Tyvek Roll with Sterrad Chemical Indicator 250 mm x 70 m
20705037015822Tyvek Roll with Sterrad Chemical Indicator 200 mm x 70 m
20705037015815Tyvek Roll with Sterrad Chemical Indicator 150 mm x 70 m
20705037015808Tyvek Roll with Sterrad Chemical Indicator 100 mm x 70 m
20705037015792Tyvek Roll with Sterrad Chemical Indicator 75 mm x 70 m

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.