Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010882984

FEI Number

3010882984

Entity Name

Therapak, LLC

City/State/Country

Claremont, CA, US

Establishment Address

651 Wharton Dr, Claremont, CA 91711, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Therapak, LLC (Owner Number: 9002081)

Owner / Operator Contact Address

651 Wharton Drive, Claremont, CA 91711, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

180ml Collection Cup, Individually Wrapped w/temp strip (CS/100) 6.5oz Beaker w/Dual Temp Strip (CS/500) Generic Split 45ml Collection Kit (CS/100) Single 45mL Vial Bag Kit 100/case Single 45mL Bulk Supply Kit (CS/100) Drug Screen Kit (CS/48) Drug Screen Kit Shipping System (CS/100) Split Foil Top Specimen Collection Kit (CS/100) Split Collection Kit (CS/50) Urine Collection Kit Bag (CS/100) Split 45 mL Vial Box Kit (CS/48) 90mL Cup w/Evidence Seal (CS/100) Single Foil Top Specimen Collection Kit (CS/100)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MPQ	Container, Specimen, Urine, Drugs Of Abuse, Over The Counter	Pathology	Class 1	864.3260	2013-07-02

Official Correspondent

Jason Gumaer

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Therapak, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044182936	Therapak, LLC	Oakwood, GA, US

Similar Registrations

Registration Number	Establishment Name	Location
3014967969	PACKAGING COMPLIANCE MEDICAL, LLC	Kentwood, MI, US
3014615175	K-MED CO., LTD.	Yangzhou Jiangsu, CN
9613910	NARANG MEDICAL, LTD.	New Delhi, IN
3004847291	OMEGA LABORATORIES, INC.	MOGADORE, OH, US
3017635043	PT. Jayamas Medica Industri Tbk	Sidoarjo Jawa Timur, ID

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010882984. Last updated year: 2026. Please use registration number 3010882984 when referencing this establishment in official correspondence.