DEVICE: PATHFINDER (09356119001034)
Device Identifier (DI) Information
PATHFINDER
PS-U-A1204
In Commercial Distribution
06R6104
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A1204
In Commercial Distribution
06R6104
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PATHFINDER 900 PLUS DDS AUTOMATED TUBE MANAGEMENT SYSTEM FOR HIGH SPEED DECAPPING AND SORTING, SET UP FOR 20 INPUT/OUTPUT POSITIONS
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
57871 | Specimen processing instrument IVD |
An 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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
LXG | Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Storage Environment Temperature: between -4 and 140 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
65d48045-e991-44de-9147-1f350f25a6c1
September 16, 2022
2
November 16, 2020
September 16, 2022
2
November 16, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+61738971600
aimlab@aimlab.com
aimlab@aimlab.com