ASP Device; ASP System; ROSE Prep pro

Basic Information

• Brand Name: ASP Device; ASP System; ROSE Prep pro
• Primary DI: 00860008222404
• Version / Model: REV P
• Catalog Number: PI-0076558
• Company Name: ASP Health Inc.
• Labeler DUNS: 050200201
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-04-05
• Public Version: 2
• Public Version Date: 2025-02-13
• Public Version Status: Update
• Public Device Record Key: 1e57d8d3-ccc6-4054-8a30-5bd8c7e6b562

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

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KPA	Slide Stainer, Automated	Pathology	864.3800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860008222404	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 20 – 80 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: 18 – 30 Degrees Celsius