AccessGUDID - DEVICE: Automate 2500 Family (15099590364083)

GUDID

Device Identifier (DI) Information

Brand Name: Automate 2500 Family
Version or Model: AutoMate 2550
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ODL25255
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590364083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: AutoMate2550 – High Speed Sorter with Aliquot Module

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQP	Calculator/Data Processing Module, For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 140 Degrees Fahrenheit
Storage Environment Humidity: between 40 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 64 and 89 Degrees Fahrenheit
Special Storage Condition, Specify: Altitude Must not exceed 6,562 ft

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 342cfdd5-662d-4902-b4ef-3720916cae73
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: August 15, 2016