FDA.reportPublic FDA data

Therapak

Primary DI
00810185250066
Brand
Therapak
Company
Therapak LLC
Model
ACSK40031
Catalog number
ACSK40031
Device description
Split Collection Kit (CS/50)
Published
2025-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MPQContainer, Specimen, Urine, Drugs Of Abuse, Over The CounterPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250066PrimaryGS10
00810185250073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250066008101852500668101852500660810185250066
00810185250073008101852500738101852500730810185250073

GMDN Terms#

Term, Definition table
TermDefinition
Drug-testing specimen collection kit IVDA covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.

Regulatory Flags#

DUNS number
791071165
Device count
50
Premarket exempt
true
Kit
true
Lot or batch
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
00810185250028TherapakTherapak LLCMPQ2025-08-11
00810185250080TherapakTherapak LLCMPQ2025-08-11
00810185250127TherapakTherapak LLCMPQ2025-08-11
00810185250141TherapakTherapak LLCMPQ2025-08-11
00810185250226TherapakTherapak LLCMPQ2025-08-11
00810185250240TherapakTherapak LLCMPQ2025-08-11
00810185250660TherapakTherapak LLCMPQ2025-08-11
00810185250035TherapakTherapak LLCMPQ2025-08-11
00810185250073TherapakTherapak LLCMPQ2025-08-11
00810185250097TherapakTherapak LLCMPQ2025-08-11
00810185250134TherapakTherapak LLCMPQ2025-08-11
00810185250158TherapakTherapak LLCMPQ2025-08-11
00810185250233TherapakTherapak LLCMPQ2025-08-11
00810185250257TherapakTherapak LLCMPQ2025-08-11
00810185250677TherapakTherapak LLCMPQ2025-08-11
00810185250103TherapakTherapak LLCMPQ2025-08-04
00810185250165TherapakTherapak LLCMPQ2025-08-04
00810185250264TherapakTherapak LLCMPQ2025-08-04
00810185250288TherapakTherapak LLCMPQ2025-08-04
00810185250301TherapakTherapak LLCMPQ2025-08-04
00810185250325TherapakTherapak LLCMPQ2025-08-04
00810185250585TherapakTherapak LLCMPQ2025-08-04
00810185250110TherapakTherapak LLCMPQ2025-08-04
00810185250172TherapakTherapak LLCMPQ2025-08-04
00810185250271TherapakTherapak LLCMPQ2025-08-04
00810185250295TherapakTherapak LLCMPQ2025-08-04
00810185250318TherapakTherapak LLCMPQ2025-08-04
00810185250332TherapakTherapak LLCMPQ2025-08-04
00810185250592TherapakTherapak LLCMPQ2025-08-04
00860012318209XpeedyCura Diagnostics Inc.MPQ2025-01-31