FDA.reportPublic FDA data

Therapak

Primary DI
00810185250486
Brand
Therapak
Company
Therapak LLC
Model
ACSK38533
Catalog number
ACSK38533
Device description
Therapak Acetic Acid 24 Hour Collection (CS/24)
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LDWFixative, Acid Containing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDWFixative, Acid ContainingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250486PrimaryGS10
00810185250493Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250486008101852504868101852504860810185250486
00810185250493008101852504938101852504930810185250493

GMDN Terms#

Term, Definition table
TermDefinition
24-hour urine specimen container IVD, preservativeA capped receptacle, typically 2 to 4 litres, containing one or multiple preservatives [e.g., boric acid (H3BO3), hydrochloric acid (HCl), sodium carbonate (Na2CO3), sulphuric acid (H2SO4)] and intended to be used for the collection, preservation, and transport of urine collected over a 24-hour period for analysis and/or other in vitro diagnostic investigation. This is a single-use device.

Regulatory Flags#

DUNS number
791071165
Device count
24
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07312058462420TherapakACSK40011ACSK400112022-12-21
07312058462437TherapakACSK40012ACSK400122022-12-21
07312058462475TherapakACSK75098ACSK750982022-12-21
07312058462642TherapakACSK37928ACSK379282022-12-21
07312058462659TherapakACSK37929ACSK379292022-12-21
07312058462673TherapakACSK38533ACSK385332022-12-21
07312058462680TherapakACSK38534ACSK385342022-12-21
07312058462697TherapakACSK38869ACSK388692022-12-21
07312058462703TherapakACSK38870ACSK388702022-12-21
07312058462727TherapakACSK38872ACSK388722022-12-21
07312058462734TherapakACSK38873ACSK388732022-12-21
07312058462741TherapakACSK38879ACSK388792022-12-21
07312058462802TherapakACSK40002ACSK400022022-12-21
07312058462819TherapakACSK40056ACSK400562022-12-21
07312058462826TherapakACSK75099ACSK750992022-12-21
07312058462833TherapakACSK75100ACSK751002022-12-21
07312058462857TherapakACSK37939ACSK379392022-12-21
07312058462871TherapakACSK40003ACSK400032022-12-21
07312058462888TherapakACSK40004ACSK400042022-12-21
07312058462901TherapakACSK40010ACSK400102022-12-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410054PathTezt®BIOCYTECH CORPORATION SDN. BHD.LDW2026-03-11
00810185250462TherapakTherapak LLCLDW2025-08-11
00810185250479TherapakTherapak LLCLDW2025-08-11
00810185250493TherapakTherapak LLCLDW2025-08-11
07312058462673TherapakTherapak LLCLDW2022-12-21
07312058462680TherapakTherapak LLCLDW2022-12-21
00845275005134Thermo Scientific Protocol™ Parasitology SystemFisher DiagnosticsLDW2016-09-16