FDA.reportPublic FDA data

Celerity

Primary DI
50724995229547
Brand
Celerity
Company
ALBERT BROWNE LIMITED
Model
LCC015
Catalog number
LCC015
Device description
Celerity Chemical Indicator for enspire 3000 CLCSPS employing S40 Sterilant.
Published
2024-04-22
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
JOJIndicator, physical/chemical sterilization process

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240032000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240032000Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation2024-04-17JOJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995229547PackageGS12In Commercial Distribution
10724995229549PrimaryGS10
00724995229542Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499522954750724995229547
1072499522954910724995229549
00724995229542007249952295427249952295420724995229542

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection solution test stripA sliver of absorbent material impregnated with chemical indicators and dyes intended to be used to rapidly indicate, through colour change, the concentration of the active ingredient in a device disinfectant and/or sterilant solution after preparation, to ensure disinfectant/sterilant properties. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Dry and Keep away from direct light
Storage Environment Humidity30 Percent (%) Relative Humidity60 Percent (%) Relative Humidity
Storage Environment Temperature43 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
218172765
Device count
50
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
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00840456207208JMUJMU DENTAL, INCJOJ2026-06-05
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00840456215180JMUJMU DENTAL, INCJOJ2026-06-05
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