FDA.report

ASP HOOD

Primary DI
10860008222425
Brand
ASP HOOD
Company
ASP Health Inc.
Model
A-03
Catalog number
PI-0077054
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.
Published
2024-04-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KPASlide Stainer, Automated

Product Code Classifications

CodeDeviceSpecialtyClass
KPASlide Stainer, AutomatedPathology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20860008222422PackageGS1480In Commercial Distribution
10860008222425PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2086000822242220860008222422
1086000822242510860008222425

GMDN Terms

TermDefinition
Microscope slide stainer IVDAn 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.

Storage And Handling

TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius50 Degrees Celsius
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
877-527-7432info@asp-health.com

Regulatory Flags

DUNS number
050200201
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00860008222404ASP Device; ASP System; ROSE Prep proREV MPI-00765582024-04-05
20860008222415ASP PODA-03PI-00770552024-04-05
20860008222439ASP VIALA-03PI-00854692024-04-05

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