FDA.reportPublic FDA data

ULTRA GI™

Primary DI
20705037069368
Brand
ULTRA GI™
Company
ADVANCED STERILIZATION PRODUCTS SERVICES INC.
Model
43400
Device description
ULTRA GI™ Cycle Process Challenge Device Vial
Published
2024-09-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRCIndicator, biological sterilization process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRCIndicator, Biological Sterilization ProcessGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K234084000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K234084000STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator (CI) Tape (14202NL); STERRAD VELOCITY™ Biological Indicator (BI) (43210) (60 count); STERRAD VELOCITY™ Biological Indicator (BI) (43210-30)(30 count); STERRAD VELOCITY™ Reader (43220); ULTRA GI™ Process Challenge Device (PCD) (43400)(30 count)Advanced Sterilization Products, Inc.2024-07-05JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705037069368PrimaryGS10
80705037069353Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503706936820705037069368
8070503706935380705037069353

GMDN Terms#

Term, Definition table
TermDefinition
Biological sterilization indicatorA sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
947451626
Device count
30
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10705037015924Tyvek®12544125442025-12-17
10705037015948Tyvek®12557125572025-12-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
107073878129323M™ Attest™3M COMPANYFRC2026-04-26
107073878129563M™ Attest™3M COMPANYFRC2026-04-26
307073875085563M™ Attest™3M COMPANYFRC2026-04-26
107073878151173M™ Attest™3M COMPANYFRC2026-04-10
107073878151243M™ Attest™3M COMPANYFRC2026-04-10
307073878129123M™ Attest™3M COMPANYFRC2026-04-10
307073878129363M™ Attest™3M COMPANYFRC2026-04-10
307073878129433M™ Attest™3M COMPANYFRC2026-04-10
307073878129503M™ Attest™3M COMPANYFRC2026-04-10
07798375773607BIOTRACE™TERRAGENE S.A.FRC2026-03-10
07798164670070Bionova®TERRAGENE S.A.FRC2025-10-16
07798164670209Bionova®TERRAGENE S.A.FRC2025-10-16
07798164673545Bionova®TERRAGENE S.A.FRC2025-10-16
07798375773539ProEdgeTERRAGENE S.A.FRC2025-10-16
10686864061257AssureCheck™TERRAGENE S.A.FRC2025-10-16
07798375773034BIOTRACE™TERRAGENE S.A.FRC2025-03-06
M9850141001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850161001Spore Strip - EO/Dry HeatMESA LABORATORIES, INC.FRC2025-01-15
M9850341001Spore StripMESA LABORATORIES, INC.FRC2025-01-15
M9850351001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M9850361001Spore Strip Steam & ChemiclaveMESA LABORATORIES, INC.FRC2025-01-15
M985051000C1Dual Spore Strips - ControlMESA LABORATORIES, INC.FRC2025-01-15
M985051000T1Dual Spore Strips - TestMESA LABORATORIES, INC.FRC2025-01-15
M985055100T1Dual Spore Strip - TestMESA LABORATORIES, INC.FRC2025-01-15
M985HFY5201017950 HealthFirst Mail-In Spore Testing Service, 52 TestsMESA LABORATORIES, INC.FRC2024-12-18
07798375772624BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772945BIOTRACE™TERRAGENE S.A.FRC2024-11-12
07798375772983BIOTRACE™TERRAGENE S.A.FRC2024-11-12
10686864060892Medicom® AssureCheck™AMD Medicom IncFRC2024-10-14
50732224721489Sporview 10 Hour Self Contained BICROSSTEX INTERNATIONAL, INC.FRC2024-04-10