AccessGUDID - DEVICE: ASP Device; ASP System; ROSE Prep pro (00860008222404)

GUDID

Device Identifier (DI) Information

Brand Name: ASP Device; ASP System; ROSE Prep pro
Version or Model: REV P
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PI-0076558
Company Name: ASP Health Inc.

Primary DI Number: 00860008222404
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 050200201 *Terms of Use

Device Description: The ASP Device is a dual-purpose microprocessor-controlled slide preparation and staining system intended to prepare cytology samples for examination. The ASP Device is intended for use in a clinic or laboratory environment by professionals who have been trained to work with cytologic specimens.

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):	Yes
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?
15599	Microscope slide stainer IVD	An automated mains electricity (AC-powered) laboratory instrument intended to be used to stain blood, tissue and/or other clinical specimens fixed to microscope examination slides, using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	Slide Stainer, Automated

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 20 and 80 Percent (%) Relative Humidity
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 18 and 30 Degrees Celsius
Storage Environment Temperature: between 18 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1e57d8d3-ccc6-4054-8a30-5bd8c7e6b562
Public Version Date: February 13, 2025
Public Version Number: 2
DI Record Publish Date: April 05, 2024