FDA.reportPublic FDA data

DART

Primary DI
50724995032796
Brand
DART
Company
STERIS CORPORATION
Model
NB113
Catalog number
NB113
Device description
The DART Daily Air Removal Test is a pre-assembled Bowie-Dick test pack product used in monitoring healthcare steam sterilizers.
Published
2016-09-09
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50724995032796PackageGS15In Commercial Distribution
10724995032798PrimaryGS10
00724995032791Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5072499503279650724995032796
1072499503279810724995032798
00724995032791007249950327917249950327910724995032791

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from direct light
Storage Environment Humidity30 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature36 Degrees Fahrenheit75 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
961394798
Device count
10
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
00724995232016NAX-Ray Table TopBF5532026-05-26
00724995232023NAX-Ray Table TopBF5542026-05-26
00724995232030NATable ExtenderBF5552026-05-26
00724995232054NAX-Ray Table TopBF6622026-05-26
00724995232061NAX-Ray Table TopBF6632026-05-26
00724995232078NAX-Ray Table TopBF6642026-05-26
00724995153724AmscoWarming CabinetDJ0301441312026-02-13
00724995153731AmscoWarming CabinetDJ04014431112026-02-13
00724995153748AmscoWarming CabinetDJ0401443312026-02-13
00724995153755AmscoWarming CabinetDJ0501441322026-02-13
00724995153762AmscoWarming CabinetDJ0501443322026-02-13
00724995153786AmscoWarming CabinetDJ0601441312026-02-13
00724995153793AmscoWarming CabinetDJ06014431132026-02-13
00724995153809AmscoWarming CabinetDJ0601443312026-02-13
00724995154165AmscoWarming CabinetDJ060144123122026-02-13
00724995158422AmscoWarming CabinetCB46210020012026-02-13
00724995222031NATable ExtensionBF002612026-02-13
00724995222055NATable ExtensionBF002632026-02-13
00724995222062NATable ExtensionBF002642026-02-13
00724995222079NATable ExtensionBF002652026-02-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810194401008AiraAIRA, LLCJOJ2026-02-10
00810194400896AiraAIRA, LLCJOJ2026-01-16
00810194400933AiraAIRA, LLCJOJ2026-01-16
00810194400964AiraAIRA, LLCJOJ2026-01-16
00810194401022AiraAIRA, LLCJOJ2026-01-16
20705037015921Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015945Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015969Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-17
20705037015914Tyvek®ADVANCED STERILIZATION PRODUCTS SERVICES INC.JOJ2025-12-16
50724995245523Rapicide PA Test StripsMEDIVATORS INC.JOJ2025-06-10
07798375772570VERISURE™TERRAGENE S.A.JOJ2025-06-03
07798375772860SEALSURE™TERRAGENE S.A.JOJ2025-06-03
00850064244045LarrTrue Indicating LLCJOJ2025-04-02
00850064244052CheetaTrue Indicating LLCJOJ2025-04-02
00615375013526MetriCide METREX RESEARCH, LLCJOJ2025-03-21
20686864061162Medicom SafeSealAMD Medicom IncJOJ2025-03-20
00850072625003Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625010Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625034Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625041Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00850072625058Arrigo Professional Supplies LLCARRIGO PROFESSIONAL SUPPLIES LLCJOJ2025-03-18
00860011103424True Indicating Sterilization Indicator TapeTrue Indicating LLCJOJ2025-03-18
00850064244038True IndicatingTrue Indicating LLCJOJ2025-02-27
10724995231504CELERITYSTERIS CORPORATIONJOJ2025-01-13
07798375772532VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772754VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772808VERISURE™TERRAGENE S.A.JOJ2024-11-13
07798375772846VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772907VERISURE™TERRAGENE S.A.JOJ2024-11-12
07798375772969VERISURE™TERRAGENE S.A.JOJ2024-11-12