FDA.reportPublic FDA data

Therapak

Primary DI
00810185250202
Brand
Therapak
Company
Therapak LLC
Model
ACSK75100
Catalog number
ACSK75100
Device description
8 Liter Histology Bucket (CS/10)
Published
2025-08-11
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NNKContainer, Specimen Mailer And Storage, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NNKContainer, Specimen Mailer And Storage, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810185250202PrimaryGS10
00810185250219Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810185250202008101852502028101852502020810185250202
00810185250219008101852502198101852502190810185250219

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. This is a single-use device.

Regulatory Flags#

DUNS number
791071165
Device count
10
Premarket exempt
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
04038917581882Salivette®Sarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916053802Tube 3.5ml, 92x13 (round), PPSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055837Screw cap, pastel-greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916055998Screw cap, pastel-orangeSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056049Screw cap, pastel-violetSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056148Screw cap, pastel-yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916056407Screw cap, pastel-blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057831SafeSeal tube 0.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916057879SafeSeal tube 0.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058012SafeSeal tube 0.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058050SafeSeal tube 0.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058135SafeSeal tube 0.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058173SafeSeal tube 0.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058210Micro tube 0.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058296SafeSeal tube 1.5mlSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058340SafeSeal tube 1.5ml, brownSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058388SafeSeal tube 1.5ml, redSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058425SafeSeal tube 1.5ml, yellowSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058463SafeSeal tube 1.5ml, greenSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058500SafeSeal tube 1.5ml, blueSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916058548Micro tube 1.5ml SafeSealSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
04066916059354Faeces tube 101x16.5mmSarstedt Aktiengesellschaft & Co.KGNNK2026-07-21
00840216129290Quest DiagnosticsAsp Global, LLCNNK2026-07-17
00840216129801LabCorpAsp Global, LLCNNK2026-07-17
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00860013988029500 Single strip cards and 500 foil-LifelineADVANCE DX, INC.NNK2026-03-03
00860013988036500 Blood Collection Card (500 Double strip cards and 500 foil-Lifeline)ADVANCE DX, INC.NNK2026-03-03
00860013988043Advance Dx 100 Blood Collection Card (single strip cards and 100 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988050Advance Dx 500 Blood Collection Card (500 single strip cards and 500 foil)ADVANCE DX, INC.NNK2026-03-03
00860013988067Advance Dx Blood Collection Card: Single strip cards - no lines on the frontADVANCE DX, INC.NNK2026-03-03