FDA.reportPublic FDA data

Tyvek Self Seal Pouch

Primary DI
20705037015754
Brand
Tyvek Self Seal Pouch
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
12340
Catalog number
12340
Device description
Tyvek Self Seal Pouch with Sterrad Chemical Indicator 200 mm x 400 mm
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103210000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103210000TYVEK SELF-SEAL POUCHES WITH STERRAD, TYVEK ROLLS WITH STERRAD, TYVEK HEAT-SEAL WITH STERRAD CHEMICAL INDICATORSAdvanced Sterilization Products2011-06-06FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037015754PackageGS12In Commercial Distribution
10705037015757PrimaryGS10
80705037015756Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503701575420705037015754
1070503701575710705037015757
8070503701575680705037015756

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a dry area away from sources of light, acids, bases and STERRAD® Sterilizer both before and after sterilization.
Special Storage Condition, Specify00Store in a dry area away from sources of light, acids, bases and STERRAD™ Sterilizer both before and after sterilization.
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)783-7723complaints@aspus.jnj.com
+1(888)783-7723ASP-Complaints@asp.com

Regulatory Flags#

DUNS number
947451626
Device count
250
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705037071319ULTRA GI™43381433812025-12-15
10705037042999STERRAD™99204992042026-06-03
10705037043002STERRAD™99205992052018-05-31
10705037043019STERRAD™99206992062018-05-31
10705037043026STERRAD™99207992072018-05-31
10705037043033STERRAD™99208992082018-05-31
10705037043040STERRAD™99209992092018-05-31
10705037043057STERRAD™99210992102018-05-31
10705037043064STERRAD™99211992112018-05-31
20705037045553CIDEX™20392203922016-09-24
20705037045560CIDEX™20393203932016-09-24
10705037067244SEALSURE™14202NL14202NL2021-02-11
10705037048908STERRAD VELOCITY™43210432102017-10-10
10705037049400STERRAD VELOCITY™43210-3043210-302017-10-10
10705037048915STERRAD™43220432202017-10-10
10705037047628STERRAD™99239992392016-09-24
10705037047635APTIMAX™99240992402016-09-24
10705037047611APTIMAX™13839138392016-09-24
10705037015979Tyvek®12560125602025-12-18
20705037015976Tyvek®12560125602025-12-18

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D771603531Dental CityICP, INC.JOJ2026-05-27
D771604231Dental CityICP, INC.JOJ2026-05-27
D771604251Dental CityICP, INC.JOJ2026-05-27
D771604271Dental CityICP, INC.JOJ2026-05-27
D771604281Dental CityICP, INC.JOJ2026-05-27
D771604291Dental CityICP, INC.JOJ2026-05-27
D771604391Dental CityICP, INC.JOJ2026-05-27
107073877931703M™ Attest™3M COMPANYJOJ2026-04-26
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10705037015955Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
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10615375013516MetriCide METREX RESEARCH, LLCJOJ2025-03-21
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07798375772624BIOTRACE™TERRAGENE S.A.JOJ2024-11-12
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