FDA.reportPublic FDA data

Therapak

Primary DI
00810185250318
Brand
Therapak
Company
Therapak LLC
Model
ACSK39449
Catalog number
ACSK39449
Device description
Split Foil Top Specimen Collection Kit (CS/100)
Published
2025-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
00810185250301PrimaryGS10
00810185250318Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250301008101852503018101852503010810185250301
00810185250318008101852503188101852503180810185250318

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
158388061
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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 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
00810185250066TherapakTherapak 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
00810185250332TherapakTherapak LLCMPQ2025-08-04
00810185250592TherapakTherapak LLCMPQ2025-08-04
00860012318209XpeedyCura Diagnostics Inc.MPQ2025-01-31