FDA.report

DART

Primary DI
10724995032811
Brand
DART
Company
STERIS CORPORATION
Model
NB215
Catalog number
NB215
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

Related Records

Contact Domains

Product Codes

CodeName
JOJIndicator, physical/chemical sterilization process

Product Code Classifications

CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10724995032811PrimaryGS10
00724995032814Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1072499503281110724995032811
00724995032814007249950328147249950328140724995032814

GMDN Terms

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

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

Contacts

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

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