FDA.reportPublic FDA data

HistoSonics

Primary DI
00850006962068
Brand
HistoSonics
Company
Histosonics, Inc.
Model
HISFL1001
Device description
Fluidics Cart
Published
2024-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JRSPurifier, Water (Absorption, Deionization, Membrane Filter, Reverse Osmosis)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850006962068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850006962068008500069620688500069620680850006962068

GMDN Terms#

Term, Definition table
TermDefinition
Combination water purification systemAn assembly of electrically-powered devices, or stand-alone device, designed to remove unwanted chemical, particulate, and/or biological contaminants from water. This system purifies water using a combination of methods including particulate filtration, chemical disinfection, deionization, reverse osmosis, and/or ultraviolet light.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8777400543info@histosonics.com

Regulatory Flags#

DUNS number
028153599
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850006962273HistoSonicsEDNTH142026-02-04
00850006962280HistoSonicsEDNTH122026-02-04
00850006962327EdisonEDNTC10012026-02-04
00850006962082EdisonEDNTC10012025-02-21
00850006962099EdisonEDNTH122025-02-21
00850006962105EdisonEDNTH142025-02-21
00850006962075HistoSonicsHISFK20012024-07-29
00850006962129HistoSonicsHISKT20002024-07-29
00850006962006EdisonEDNTC10012023-12-07
00850006962020EdisonEDNTH02122023-12-07
00850006962037EdisonEDNTH08142023-12-07
00850006962044EdisonEDNSA10012023-12-07
00850006962051EdisonEDNCK20012023-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G212WS20301WaterSoftIbt Scientific LLCJRS2025-12-12
G212WS21350WaterSoft 0-30Ibt Scientific LLCJRS2025-12-12
00810000521579PureClarity™PARKELL, INC.JRS2024-12-13
00810000521647PureClarity™PARKELL, INC.JRS2024-12-13
00850006962075HistoSonicsHistosonics, Inc.JRS2024-07-29
00380740138783AlinityAbbott GmbHJRS2023-11-16
00858293006342Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18
10858293006349Water Hardness Test StripREPROCESSING PRODUCTS CORPORATIONJRS2019-06-18