Celerity

Primary DI
50724995218589
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
New
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
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

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213262000CELERITY HP Chemical IndicatorSTERIS Corporation2022-01-07QKM

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 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
218172765
Device count
200
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
false
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
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
10724995218581CelerityPCC079PCC0792022-08-10
10724995092945VERIFYLCC016LCC0162016-09-06
10724995091108VERIFYPCC046PCC0462016-09-06
10724995084629VERIFYPCC005PCC0052016-09-06
10724995084636VERIFYPCC007PCC0072016-09-06
10724995084643VERIFYPCC008PCC0082016-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995218581CelerityALBERT 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