FDA.reportPublic FDA data

Therapak

Primary DI
00810185250509
Brand
Therapak
Company
Therapak LLC
Model
ACSK38107
Catalog number
ACSK38107
Device description
Blood Alcohol Collection and Transport Kit (CS/24)
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
KSTSystem, Blood Collection, Vacuum-Assisted, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSTSystem, Blood Collection, Vacuum-Assisted, ManualHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250509PrimaryGS10
00810185250516Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250509008101852505098101852505090810185250509
00810185250516008101852505168101852505160810185250516

GMDN Terms#

Term, Definition table
TermDefinition
Capillary blood collection set, professionalA collection of devices intended to be used by a healthcare professional at the point-of-care to collect a capillary blood sample from a patient for subsequent diagnostic testing or screening purposes. It typically includes a lancet and a blood collection device (consisting of a capillary tube and blood collection tube) and may also include gloves, gauze pads, alcohol pads and dressings. This is a single-use device.

Regulatory Flags#

DUNS number
791071165
Device count
24
Premarket exempt
true
Kit
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
00850024924109Labcorp Comfort DrawMEDTOX DIAGNOSTICS, INC.KST2026-05-22
H671ABCTD0ABC TinyDrawUTAH MEDICAL PRODUCTS, INC.KST2025-09-18
00850033131116Enhanced HARegenlab USA LLCKST2025-08-29
00810185250516TherapakTherapak LLCKST2025-08-11
04719875918100Transcend Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-08-07
20193489189664MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
30193489189661MEDLINEMEDLINE INDUSTRIES, INC.KST2025-07-10
10810100050457KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050587KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172676KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050078KBMEDKB Medical (group), Inc.KST2025-05-21
00850016172013KBMEDKB Medical (group), Inc.KST2025-05-21
10810100050075KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050450KBMEDKB Medical (group), Inc.KST2025-05-21
00810100050580KBMEDKB Medical (group), Inc.KST2025-05-21
10850016172010KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050454KBMEDKB Medical (group), Inc.KST2025-05-21
20810100050584KBMEDKB Medical (group), Inc.KST2025-05-21
20850016172673KBMEDKB Medical (group), Inc.KST2025-05-21
04719875918070Aeon Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
04719875918094Virtue Blood Collection Tube HolderAEON BIOTHERAPEUTICS CORP.KST2025-05-15
10888277415461MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
20888277415468MEDLINEMEDLINE INDUSTRIES, INC.KST2025-05-08
06974481839128Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974481839125Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
06974481839142Needle HolderGuangzhou Improve Medical Instruments Co., Ltd.KST2025-03-14
16974594960051N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960068N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960082N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01
16974594960099N/AHBH BIOTECHNOLOGY LIMITEDKST2025-03-01