FDA.reportPublic FDA data

Therapak

Primary DI
00810185250196
Brand
Therapak
Company
Therapak LLC
Model
ACSK37939
Catalog number
ACSK37939
Device description
Flow Cytometry / Molecular Pathology Collection/ Transport Kit (CS/30)
Published
2025-08-11
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
OFZBlood Specimen Collection Kit (Excludes Hiv Testing)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OFZBlood Specimen Collection Kit (Excludes Hiv Testing)Anesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250189PrimaryGS10
00810185250196Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250189008101852501898101852501890810185250189
00810185250196008101852501968101852501960810185250196

GMDN Terms#

Term, Definition table
TermDefinition
General specimen collection kit IVD, clinicalA collection of in vitro diagnostic devices intended exclusively for professional use for the collection, and preservation and/or transport, of more than one type of clinical specimen (e.g., urine, faeces, sputum, mucous, vaginal secretions) derived from different body regions for in vitro diagnostic investigation [e.g., nucleic acid technique (NAT), histopathology]. The kit consists of a specimen sampling/collection tool(s) [e.g., swab, brush, spatula], and a covered specimen receptacle with or without an additive/medium (e.g., preservation solution, microbiological medium). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
791071165
Device count
30
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
true
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
00810185250189TherapakTherapak LLCOFZ2025-08-11
10198956098077CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
50198956098075CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-06-30
10198956070578CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
50198956070576CARDINAL HEALTHCardinal Health 200, LLCOFZ2025-05-13
10809160416594Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
20809160416591Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2024-01-11
00810094575809CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
00810094575854CuraplexBOUND TREE MEDICAL, LLCOFZ2023-04-30
07312058462857TherapakTherapak LLCOFZ2022-12-21
00860193001730KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
00860193001747KidneyCare Specimen Collection KitCAREDX, INC.OFZ2022-10-31
10195594754068CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
50195594754066CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-08-04
10809160371947Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
20809160371944Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2022-05-31
10195594560362CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
50195594560360CARDINAL HEALTHCardinal Health 200, LLCOFZ2022-02-24
10888439848830CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
50888439848838CARDINAL HEALTHCardinal Health 200, LLCOFZ2020-06-26
00860193001709AlloSure Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001716Allomap Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00860193001723HeartCare Specimen Collection KitCAREDX, INC.OFZ2020-04-30
00191072107268ACSAMERICAN CONTRACT SYSTEMS, INC.OFZ2020-04-06
00812277035247CuraplexBOUND TREE MEDICAL, LLCOFZ2019-07-01
10809160240779Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
20809160240776Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2019-05-23
15060498451533Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
25060498451530Motion Medical DistributingHaslam Medical, Inc.OFZ2017-06-07
10809160149454Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.OFZ2017-06-06