FDA.reportPublic FDA data

AssureCheck™

Primary DI
10686864061233
Brand
AssureCheck™
Company
TERRAGENE S.A.
Model
ST0005
Device description
AssureCheck™ Type 5 Chemical Indicator for monitoring steam sterilization processes
Published
2025-10-16
Public version status
New
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
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20686864061230PackageGS110In Commercial Distribution
10686864061233PrimaryGS10
00686864061236Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068686406123020686864061230
1068686406123310686864061233
00686864061236006868640612366868640612360686864061236

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-361-2862enquiry@medicom.ca

Regulatory Flags#

DUNS number
970856911
Device count
250
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07798375773607BIOTRACE™731202026-03-10
07798375773591BIOTRACE™731202026-03-10
07798375772815VERISURE™732602025-06-03
07798375772853SEALSURE™732702025-06-03
07798375772570VERISURE™732602025-06-03
07798375772860SEALSURE™732702025-06-03
07798164670070Bionova®BT202025-10-16
07798164670209Bionova®BT202025-10-16
07798164673545Bionova®BT202025-10-16
07798375773539ProEdgeSM-BIOIN2025-10-16
10686864061240AssureCheck™ST00042025-10-16
10686864061257AssureCheck™ST10202025-10-16
00686864061267AssureCheck™ST20002025-10-16
07798164678434Bionova®KPCD224-22022-03-21
07798164678441Bionova®KPCD224-22022-03-21
07798164678472Bionova®KPCD222-22022-03-21
07798164678489Bionova®KPCD222-22022-03-21
07798164678496Bionova®KPCD220-C2022-03-21
07798164678502Bionova®KPCD220-C2022-03-21
07798164678519Bionova®KPCD220-22022-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
107073877931703M™ Attest™3M COMPANYJOJ2026-04-26
10705037015979Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-18
10705037015924Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015948Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015955Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015962Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
10705037015917Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
10686864061240AssureCheck™TERRAGENE S.A.JOJ2025-10-16
10724995245525Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
07798375772815VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772853SEALSURE™TERRAGENE S.A.JOJ2025-06-03
10615375013516MetriCide METREX RESEARCH, LLCJOJ2025-03-21
10686864061165Medicom SafeSealAMD Medicom IncJOJ2025-03-20
07798375772730VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772747VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772792VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772624BIOTRACE™TERRAGENE S.A.JOJ2024-11-12
07798375772839VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772891VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772952VERISURE™TERRAGENE S.A.JOJ2024-11-12
10724995229549CelerityALBERT BROWNE LIMITEDJOJ2024-04-22
10724995229495VERIFYALBERT BROWNE LIMITEDJOJ2024-04-08
07798375772259VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772266VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772280VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772297VERISURE™TERRAGENE S.A.JOJ2023-11-13
07798375772303SEALSURE™TERRAGENE S.A.JOJ2023-11-13
07798375772327BIOTRACE™TERRAGENE S.A.JOJ2023-11-13
10724995217362Revital-OxALBERT BROWNE LIMITEDJOJ2023-08-31
10326053118491Regard™Resource Optimization & Innovation, L.L.C.JOJ2023-05-26