FDA.reportPublic FDA data

PATHFINDER

Primary DI
09356119002413
Brand
PATHFINDER
Company
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
Model
PS-U-A711
Catalog number
06R6302
Device description
PATHFINDER 350D PLUS DECAPPER DOUBLE SORTER, 12-16MM OD TUBES
Published
2020-11-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXGEquipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09356119002413PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09356119002413093561190024139356119002413

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVDAn electrically-powered instrument or platform intended to be used for the automated or semi-automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit140 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+61738971600aimlab@aimlab.com

Regulatory Flags#

DUNS number
745595413
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09356119001003PATHFINDERPS-U-A120106R61012020-11-16
09356119001010PATHFINDERPS-U-A120206R61022020-11-16
09356119001027PATHFINDERPS-U-A120306R61032020-11-16
09356119001034PATHFINDERPS-U-A120406R61042020-11-16
09356119001041PATHFINDERPS-U-A120506R61052020-11-16
09356119001058PATHFINDERPS-U-A120606R61062020-11-16
09356119001065PATHFINDERPS-U-A120706R61072020-11-16
09356119001072PATHFINDERPS-U-A120806R61082020-11-16
09356119001089PATHFINDERPS-U-A121006R61092020-11-16
09356119002000PATHFINDERPS-U-A60506R60012020-11-16
09356119002208PATHFINDERPS-U-A07004Z73012020-11-16
09356119002215PATHFINDERPS-U-A06904Z73022020-11-16
09356119002222PATHFINDERPS-U-A08404Z73032020-11-16
09356119002406PATHFINDERPS-U-A71006R63012020-11-16

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Primary DI, Brand, Company table
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