DEVICE: PATHFINDER (09356119001058)
Device Identifier (DI) Information
PATHFINDER
PS-U-A1206
In Commercial Distribution
06R6106
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PS-U-A1206
In Commercial Distribution
06R6106
AIM LAB AUTOMATION TECHNOLOGIES PTY LTD
PATHFINDER 900 PLUS DDCS AUTOMATED TUBE MANAGEMENT SYSTEM FOR HIGH SPEED DECAPPING, CAPPING 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
60f9060b-19f5-4ebf-b56a-f51896a38db5
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