Chemdye®

Primary DI
07798164672142
Brand
Chemdye®
Company
TERRAGENE S.A.
Model
CD40
Device description
Chemical indicator strip for monitoring hydrogen peroxide sterilization processes.
Published
2021-01-08
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
QKMA Chemical Vapor Sterilization Multivariable Chemical Indicator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKMA Chemical Vapor Sterilization Multivariable Chemical IndicatorGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07798164672142PrimaryGS10
07798164676843Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07798164672142077981646721427798164672142
07798164676843077981646768437798164676843

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
+5493415587007info@terragene.com

Regulatory Flags#

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

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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07798375773539ProEdgeSM-BIOIN2025-10-16
10686864061233AssureCheck™ST00052025-10-16
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218581CelerityALBERT BROWNE LIMITEDQKM2022-08-10
50724995218589CelerityALBERT BROWNE LIMITEDQKM2022-08-10
07798164672135Chemdye®TERRAGENE S.A.QKM2022-03-24
07798164676843Chemdye®TERRAGENE S.A.QKM2021-01-08
307073877880023M™ Attest™3M COMPANYQKM2020-07-20
307073877880193M™ Attest™3M COMPANYQKM2020-07-20
007073877880013M™ Attest™3M COMPANYQKM2020-07-20
507073877880133M™ Attest™3M COMPANYQKM2020-07-20
50724995164749CelerityALBERT BROWNE LIMITEDQKM2019-11-01