Celerity

Primary DI
10724995218581
Brand
Celerity
Company
ALBERT BROWNE LIMITED
Model
PCC079
Catalog number
PCC079
Device description
Celerity HP Multivariable CI is designed for routine monitoring of Lumen, Non-Lumen, Flexible, Fast Non Lumen, Fast sterilization cycle of a V-PRO Low Temperature Sterilization System, or Standard, Advanced, Express, Flex Scope or Duo cycles of an ASP STERRAD System, including those systems with ALLClear Technology.
Published
2022-08-10
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213262000
K231488000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213262000CELERITY HP Chemical IndicatorSTERIS Corporation2022-01-07QKM
K231488000Celerity™ HP Chemical Indicator; Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator TapeSteris2023-08-07JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995218589PackageGS140In Commercial Distribution
10724995218581PrimaryGS10
00724995218584Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499521858950724995218589
1072499521858110724995218581
00724995218584007249952185847249952185840724995218584

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.

Contacts#

Phone, Email table
PhoneEmail
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
218172765
Device count
200
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10724995220614VERIFYU504U5042025-12-17
00724995220617VERIFYU504U5042025-12-17
10724995087972VerifyLCC012LCC0122025-08-05
10724995087958VerifyLCC010LCC0102025-08-05
00724995087975VerifyLCC012LCC0122025-08-05
10724995231887VERIFYLCC027LCC0272025-05-29
00724995231897VERIFYLCC028LCC0282025-05-29
50724995231885VERIFYLCC027LCC0272025-05-29
10724995164741CelerityPCC0075PCC0752019-11-01
10724995172197VERIFYPCC029PCC0292020-05-29
10724995087941VERIFYPCC029PCC0292016-09-06
10724995164734CelerityPCC074PCC0742020-04-10
10724995172180CelerityPCC076PCC0762019-06-14
10724995172234VERIFYRK019RK0192020-05-29
10724995092945VERIFYLCC016LCC0162016-09-06
10724995091108VERIFYPCC046PCC0462016-09-06
10724995084629VERIFYPCC005PCC0052016-09-06
10724995084636VERIFYPCC007PCC0072016-09-06
10724995084643VERIFYPCC008PCC0082016-09-06
10724995084650VERIFYPCC006PCC0062016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50724995218589CelerityALBERT BROWNE LIMITEDQKM2022-08-10
07798164672135Chemdye®TERRAGENE S.A.QKM2022-03-24
07798164672142Chemdye®TERRAGENE S.A.QKM2021-01-08
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