Therapak L L C

FDA Filings

This page includes the latest FDA filings for Therapak L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Therapak L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• Jason Gumaer

FDA Registration(s)

• Registration Number: 3006450277
• FEI Number: 3006450277
• Name: THERAPAK, LLC
• Owner & Operator: Therapak, LLC
• Contact Address: 651 Wharton Drive ; Claremont CA 91711 US
• Official Correspondent:
  • Lisa Johnson
  • 1-805-5662862-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 4305 Hamilton Mill Rd Ste 200 ; BUFORD, GA 30518 US
• Establishment Type:
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Develop Specifications But Do Not Manufacture At This Facility

• Registration Number: 3010882984
• FEI Number: 3010882984
• Name: Therapak, LLC
• Owner & Operator: Therapak, LLC
• Contact Address: 651 Wharton Drive ; Claremont CA 91711 US
• Official Correspondent:
  • Lisa Johnson
  • 1-805-5662862-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 651 Wharton Dr ; Claremont, CA 91711 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)

FDA Filings

Device Company	Device	Date
GUDID 07312058462468 Therapak LLC	Therapak CSTG74910	2023-02-10
GUDID 07312058462932 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462895 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462864 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462796 Therapak LLC	Therapak ACSK39473	2022-12-15
GUDID 07312058462789 Therapak LLC	Therapak ACSK39470	2022-12-15
GUDID 07312058462772 Therapak LLC	Therapak ACSK39449	2022-12-15
GUDID 07312058462758 Therapak LLC	Therapak ACSK39448	2022-12-15
GUDID 07312058462710 Therapak LLC	Therapak ACSK38871	2022-12-15
GUDID 07312058462598 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462581 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462543 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462536 Therapak LLC	Therapak	2022-12-15
GUDID 07312058462499 Therapak LLC	Therapak ACSK39416	2022-12-15
GUDID 07312058462444 Therapak LLC	Therapak CSTG74850	2022-12-15
GUDID 07312058462413 Therapak LLC	Therapak	2022-12-15
KET Therapak, LLC	NP Screen Specimen Collection Kit	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Taiwan)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Singapore)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Philippines)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Malaysia)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Indonesia)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (Hong Kong)	2017-04-26
KET Therapak, LLC	NP Screen Specimen Collection Kit (China)	2017-04-26
LDZ THERAPAK, LLC	Reagent Alcohol, 70%	2017-02-22
LDZ THERAPAK, LLC	Cytology Vial, 70% Reagent Alcohol G-DOT	2017-02-22
LDW THERAPAK, LLC	24 HR Collection Container with 30 mL Hydrochloric Acid	2015-08-11
LDW THERAPAK, LLC	24 HR Collection Container with 30 mL Acetic Acid	2015-08-11
HTD THERAPAK, LLC	Professional medical disposable plastic tweezer 11cm	2015-04-10
NNL Therapak, LLC	Category B Ambient - 95kPa Bag, Insulated Envelope, Gel Wrap	2015-03-04
NNL Therapak, LLC	Afirma (family name)	2015-03-04
NNL THERAPAK, LLC	Category B Ambient - 95kPa Bag, Insulated Envelope, Gel Wrap	2015-03-04
NNL THERAPAK, LLC	Afirma (family name)	2015-03-04
KST Therapak, LLC	Therapak DUI/DUID Kit	2014-09-18
KST Therapak, LLC	Therapak DUI Kit	2014-09-18
KST Therapak, LLC	Therapak Blood-Alcohol kit	2014-09-18
KST Therapak, LLC	Therapak Blood-Alcohol Collection and Transport Kit	2014-09-18
KST Therapak, LLC	Therapak Blood Alcohol Collection & Transport Kit	2014-09-18
KST Therapak, LLC	Clinical Trial Collection Kits	2014-09-18
KST THERAPAK, LLC	Therapak DUI/DUID Kit	2014-09-18
KST THERAPAK, LLC	Therapak DUI Kit	2014-09-18
KST THERAPAK, LLC	Therapak Blood-Alcohol kit	2014-09-18
KST THERAPAK, LLC	Therapak Blood-Alcohol Collection and Transport Kit	2014-09-18
KST THERAPAK, LLC	Therapak Blood Alcohol Collection & Transport Kit	2014-09-18
KST THERAPAK, LLC	Clinical Trial Collection Kits	2014-09-18
KDD THERAPAK, LLC	THERAPAK 3mm SKIN BIOPSY PUNCH KIT	2014-06-05
OIE THERAPAK, LLC	Urine Cytology/FISH Kit	2014-05-02
OIE THERAPAK, LLC	Urine Cytology Kit	2014-05-02
OIE THERAPAK, LLC	Urine Cytology Collection Kit	2014-05-02
OIE THERAPAK, LLC	Urine Cytology / FISH Testing Collection and Transport Kit	2014-05-02
OFZ Therapak, LLC	Venipuncture Kit	2014-05-02
OFZ Therapak, LLC	NS Bone Marrow with Bouins	2014-05-02
OFZ Therapak, LLC	Molecular Diagnostic Kit	2014-05-02
OFZ Therapak, LLC	Generic Flow Cytogenetics Molecular Collection and Transport Kit	2014-05-02
OFZ Therapak, LLC	Flow/Cytometry Kit	2014-05-02
OFZ Therapak, LLC	Flow Cytometry/Molecular Biopsy Kit	2014-05-02
OFZ Therapak, LLC	Flow Cytogenetics Molecular Collection & Transport Kit	2014-05-02
OFZ Therapak, LLC	Flow /Cytogenetics Molecular Kit	2014-05-02
OFZ Therapak, LLC	Bone Marrow Specimen Kit	2014-05-02
OFZ Therapak, LLC	Bone Marrow Kit	2014-05-02
OFZ Therapak, LLC	Bone Marrow Biopsy Transport Kit	2014-05-02
OFZ THERAPAK, LLC	Venipuncture Kit	2014-05-02
OFZ THERAPAK, LLC	NS Bone Marrow with Bouins	2014-05-02
OFZ THERAPAK, LLC	Molecular Diagnostic Kit	2014-05-02
OFZ THERAPAK, LLC	Generic Flow Cytogenetics Molecular Collection and Transport Kit	2014-05-02
OFZ THERAPAK, LLC	Flow/Cytometry Kit	2014-05-02
OFZ THERAPAK, LLC	Flow Cytometry/Molecular Biopsy Kit	2014-05-02
OFZ THERAPAK, LLC	Flow Cytogenetics Molecular Collection & Transport Kit	2014-05-02
OFZ THERAPAK, LLC	Flow /Cytogenetics Molecular Kit	2014-05-02
OFZ THERAPAK, LLC	Bone Marrow Specimen Kit	2014-05-02
OFZ THERAPAK, LLC	Bone Marrow Kit	2014-05-02
OFZ THERAPAK, LLC	Bone Marrow Biopsy Transport Kit	2014-05-02
FCH Therapak, LLC	Prostate Biopsy-Histology Cassette Transport Kit	2014-05-02
FCH Therapak, LLC	Prostate Biopsy Transport Kit - 8 vial	2014-05-02
FCH Therapak, LLC	Prostate Biopsy Transport Kit - 6 vial	2014-05-02
FCH Therapak, LLC	Prostate Biopsy Transport Kit - 16 vial	2014-05-02
FCH Therapak, LLC	Prostate Biopsy Transport Kit - 14 vial	2014-05-02
FCH Therapak, LLC	Prostate Biopsy Transport Kit - 12 vial	2014-05-02
FCH Therapak, LLC	GI Biopsy Transport Kit - 6-vial	2014-05-02
FCH Therapak, LLC	GI Biopsy Transport Kit - 2-vial	2014-05-02
FCH Therapak, LLC	GI Biopsy Kit, 6 Vial	2014-05-02
FCH Therapak, LLC	GI Biopsy Kit, 2 Vial	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy-Histology Cassette Transport Kit	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy Transport Kit - 8 vial	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy Transport Kit - 6 vial	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy Transport Kit - 16 vial	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy Transport Kit - 14 vial	2014-05-02
FCH THERAPAK, LLC	Prostate Biopsy Transport Kit - 12 vial	2014-05-02
FCH THERAPAK, LLC	GI Biopsy Transport Kit - 6-vial	2014-05-02
FCH THERAPAK, LLC	GI Biopsy Transport Kit - 2-vial	2014-05-02
FCH THERAPAK, LLC	GI Biopsy Kit, 6 Vial	2014-05-02
FCH THERAPAK, LLC	GI Biopsy Kit, 2 Vial	2014-05-02
JRC THERAPAK, LLC	7 mL Transfer Pipette - Graduated to 3 mL	2013-10-21
JRC THERAPAK, LLC	5 mL Transfer Pipette - Graduated to 2 mL	2013-10-21
JRC THERAPAK, LLC	5 mL Transfer Pipette - Graduated to 1 mL	2013-10-21
NNK Therapak, LLC	Urine Transfer Cup w/ Temp StripUrine Transfer Cup w/ Temp Strip	2013-09-13
NNK Therapak, LLC	StoneScreen? kidney stone collection cup	2013-09-13
NNK Therapak, LLC	StoneScreen? Collection and Transport Kit	2013-09-13
NNK Therapak, LLC	Small 95kPa Canister	2013-09-13
NNK Therapak, LLC	Single Tube Bottle	2013-09-13
NNK Therapak, LLC	Single Tube 95kPa Biohazard Mailer	2013-09-13
NNK Therapak, LLC	Single Ambient Wide Mouth System	2013-09-13
NNK Therapak, LLC	Single Ambient 60 mL System, Category A	2013-09-13
NNK Therapak, LLC	Multiple Tube 95kPa Biohazard Mailer	2013-09-13
NNK Therapak, LLC	Multiple Container 95kPa Biohazard Mailer	2013-09-13
NNK Therapak, LLC	Category B Ambient - Large 95kPa Bag, 18 Tubes	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Small Canister	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Medium Canister	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Medium Canister, Shuttle	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Bag, Zorb Sheet	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Bag, Tube Shuttle	2013-09-13
NNK Therapak, LLC	Category B Ambient - 95kPa Bag, 6-Tube	2013-09-13
NNK Therapak, LLC	8 Liter Histology Container	2013-09-13
NNK Therapak, LLC	5 Liter Histology Container	2013-09-13
NNK Therapak, LLC	2 Litre Histology Container	2013-09-13
NNK Therapak, LLC	2 Liter Histology Container	2013-09-13
NNK Therapak, LLC	120 ml Specimen Container	2013-09-13
NNK Therapak, LLC	120 mL Multi-Tube Container	2013-09-13
NNK THERAPAK, LLC	Urine Transfer Cup w/ Temp StripUrine Transfer Cup w/ Temp Strip	2013-09-13
NNK THERAPAK, LLC	StoneScreen? kidney stone collection cup	2013-09-13
NNK THERAPAK, LLC	StoneScreen? Collection and Transport Kit	2013-09-13
NNK THERAPAK, LLC	Small 95kPa Canister	2013-09-13
NNK THERAPAK, LLC	Single Tube Bottle	2013-09-13
NNK THERAPAK, LLC	Single Tube 95kPa Biohazard Mailer	2013-09-13
NNK THERAPAK, LLC	Single Ambient Wide Mouth System	2013-09-13
NNK THERAPAK, LLC	Single Ambient 60 mL System, Category A	2013-09-13
NNK THERAPAK, LLC	Multiple Tube 95kPa Biohazard Mailer	2013-09-13
NNK THERAPAK, LLC	Multiple Container 95kPa Biohazard Mailer	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - Large 95kPa Bag, 18 Tubes	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Small Canister	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Medium Canister	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Medium Canister, Shuttle	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Bag, Zorb Sheet	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Bag, Tube Shuttle	2013-09-13
NNK THERAPAK, LLC	Category B Ambient - 95kPa Bag, 6-Tube	2013-09-13
NNK THERAPAK, LLC	8 Liter Histology Container	2013-09-13
NNK THERAPAK, LLC	5 Liter Histology Container	2013-09-13
NNK THERAPAK, LLC	2 Litre Histology Container	2013-09-13
NNK THERAPAK, LLC	2 Liter Histology Container	2013-09-13
NNK THERAPAK, LLC	120 ml Specimen Container	2013-09-13
NNK THERAPAK, LLC	120 mL Multi-Tube Container	2013-09-13
MPQ Therapak, LLC	Urine Collection Kit Bag	2013-07-02
MPQ Therapak, LLC	Urine Collection Kit Bag - No Tamper Seal	2013-07-02
MPQ Therapak, LLC	Split Foil-Top Collection Kit	2013-07-02
MPQ Therapak, LLC	Split Foil-Top Collection Box Kit	2013-07-02
MPQ Therapak, LLC	Split Collection Kit w/2 Bags	2013-07-02
MPQ Therapak, LLC	Split Collection Box Kit	2013-07-02
MPQ Therapak, LLC	Split Collection Bag Kit	2013-07-02
MPQ Therapak, LLC	Split 45mL Bulk Supply Kit	2013-07-02
MPQ Therapak, LLC	Split 45 mL Vial Box Kit	2013-07-02
MPQ Therapak, LLC	Split 45 mL Vial Bag Kit	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 90 mL sterile urine container with temperature strip	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 90 mL sterile urine container with temperature strip and transport bag	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 90 mL sterile urine container with temperature strip and evidence seal	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 90 mL sterile urine container with evidence seal	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 90 mL sterile urine container with evidence seal, temperature strip, and transport bag	2013-07-02
MPQ Therapak, LLC	Single Specimen Collection Kits - 6.5 oz collection cup with temperature strip	2013-07-02
MPQ Therapak, LLC	Single Foil-Top Collection Kit	2013-07-02
MPQ Therapak, LLC	Single Foil-Top Collection Box Kit	2013-07-02
MPQ Therapak, LLC	Single 45mL Bulk Supply Kit	2013-07-02
MPQ Therapak, LLC	Single 45 mL Vial Box Kit	2013-07-02
MPQ Therapak, LLC	Single 45 mL Vial Bag Kit	2013-07-02
MPQ Therapak, LLC	Drug Screen Kit Shipping System	2013-07-02
MPQ Therapak, LLC	Drug Screen Kit Box Shipping System	2013-07-02
MPQ Therapak, LLC	90mL Cup w/Evidence Seal	2013-07-02
MPQ Therapak, LLC	90 mL cup w/temp strip	2013-07-02
MPQ Therapak, LLC	60ml x 53mm Sterile White Cap Dual Click Container w/ Temp Strip	2013-07-02
MPQ Therapak, LLC	60ml x 53mm Sterile White Cap Container w/ Temp	2013-07-02
MPQ Therapak, LLC	6.5 oz. Beaker w/ Temp	2013-07-02
MPQ Therapak, LLC	6.5 oz Beaker Cup w/Temp Strip	2013-07-02
MPQ Therapak, LLC	45 mL Transport Vial	2013-07-02
MPQ Therapak, LLC	180ml Collection Cup, Individually Wrapped w/ Temp Strip	2013-07-02
PMN K930955 | HHT THERAPAK, LLC	ROVERS SPATULA	2007-07-31
PMN K930955 | HHT THERAPAK, LLC	ROVERS ENDOCERVEX BRUSH	2007-07-31
PMN K930955 | HHT THERAPAK, LLC	ROVERS CERVEX BRUSH	2007-07-31
PMN K002520 | HHT THERAPAK, LLC	ROVERS SPATULA	2007-07-31
PMN K002520 | HHT THERAPAK, LLC	ROVERS ENDOCERVEX BRUSH	2007-07-31
PMN K002520 | HHT THERAPAK, LLC	ROVERS CERVEX BRUSH	2007-07-31
PMN K001119 | HHT THERAPAK, LLC	ROVERS SPATULA	2007-07-31
PMN K001119 | HHT THERAPAK, LLC	ROVERS ENDOCERVEX BRUSH	2007-07-31
PMN K001119 | HHT THERAPAK, LLC	ROVERS CERVEX BRUSH	2007-07-31

Related Finance Registrations

NCAGE Code	4HBP5	THERAPAK LLC
CAGE Code	4HBP5	THERAPAK LLC
S.A.M. Registration	4HBP5 [158388061]	THERAPAK LLC
DUNS	158388061	Therapak LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020090250074	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC BAGS ABSORBENT SHEET	755 CTN
2020081036438	Shanghai ,China (Mainland) -> Long Beach, California	PLASTIC BAGS ABSORBENT SHEET	695 CTN
202007085402	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN
202007044298	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN
202007037645	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN
2020063012847	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN
2020062712374	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN
2020062417565	Stadersand,Federal Republic of Germany -> Los Angeles, California	PACKED ON 5 PALLETS S.L.A.C. PLASTIC CUPS HS CODE 3926.90.9910 SCAC SSLL AMS REF. LAX232784	75 CTN