FDA.reportPublic FDA data

DART

Primary DI
10724995032798
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844512000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844512000DART DAILY AIR REMOVAL TESTAmerican Sterilizer Co.1985-03-21JOJ

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 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
Special Storage Condition, Specify00Keep away from direct light
Storage Environment Humidity00
Storage Environment Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
868205779
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

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00724995170493HarmonyAIRG-Series SuspensionLK00162020-05-19
00724995185886HarmonyAIRA-Series Suspension SystemLAS30NC012020-05-28
00724995185893HarmonyAIRA-Series Suspension SystemLAS30NC022020-05-28
00724995185909HarmonyAIRA-Series Suspension SystemLAS30NCND2020-05-28
00724995185916HarmonyAIRA-Series Suspension SystemLAS30NC01T2020-05-28
00724995185923HarmonyAIRA-Series Suspension SystemLAS30NC02T2020-05-28
00724995185930HarmonyAIRA-Series Suspension SystemLAS30NCNDT2020-05-28
00724995185947HarmonyAIRA-Series Suspension SystemLAS52NC012020-05-28
00724995185954HarmonyAIRA-Series Suspension SystemLAS52NC022020-05-28
00724995185961HarmonyAIRA-Series Suspension SystemLAS52NCND2020-05-28

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