ASP HOOD

Basic Information

• Brand Name: ASP HOOD
• Primary DI: 10860008222425
• Version / Model: A-03
• Catalog Number: PI-0077054
• 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: 1
• Public Version Date: 2024-04-15
• Public Version Status: New
• Public Device Record Key: 03fbbd83-2ef0-40be-add8-d8a7531de1d2

Device Description

The ASP HOOD is intended to be used only with the ASP Device, ASP System, and ROSE Prep Pro - DI number: 00860008222404. The ASP HOOD protects the user from exposure to potentially hazardous material and prevents possible sample cross contamination by sealing and containing the staining reagents and sample during device operation.

Device Characteristics

• Single Use: Yes
• 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: No
• Has Lot/Batch Number: Yes
• 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	10860008222425	GS1
Package	20860008222422	GS1	Multipack	480	In Commercial Distribution

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: -20 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -20 – 50 Degrees Celsius