Jason Gumaer

FDA Filings

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

FDA Registration(s)
Registration Number9680836
FEI Number3005892511
NameJason Gumaer
Owner & OperatorBIO NUCLEAR DIAGNOSTICS, INC.
Contact Address1791 ALBION RD. --
TORONTO, ONTARIO CA-NOTA M9W 5S7 CA
Official Correspondent
  • S. - CHOUDHRY
  • 01-416-6741545-x
US Agent
Importing Logistics Registration
ImporterFUJIFILM SONOSITE MANUFACTURING,LLC
Address21919 30TH DRIVE SE
Bothell, WA 98021 UNITED STATES
Importing Logistics Registration
ImporterWATAUGA HEALTHCARE
Address501 E WATAUGA AVE
JC, TN 37601 UNITED STATES
Email Addresswataugahealthcarejc@gmail.com
Importer TypeEND USER
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address651 Wharton Drive
Claremont, CA 91711 US
Establishment Type
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

Registration Number9680221
FEI Number1000183403
NameJason Gumaer
Owner & OperatorROVERS MEDICAL DEVICES B.V.
Contact AddressLEKSTRAAT 10 --
OSS NL-NOTA 5347 KV NL
Official Correspondent
  • IR. M.D. - ZWART
  • 31-412-648870-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address651 Wharton Drive
Claremont, CA 91711 US
Establishment TypeManufacture Medical Device

Registration Number3013548489
FEI Number3013548489
NameJason Gumaer
Owner & OperatorAdvance Sentry Corporation
Contact Address148 Plymouth Rd.
Needham MA 02492 US
Official Correspondent
  • John H Phillips
  • 1-416-6286033-x
US Agent
Importing Logistics Registration
ImporterPrimex Clinical Laboratories, Inc.
Address16742 Stagg Street
Van Nuys, CA 91406 UNITED STATES
Phone1 818 7790496
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address651 Wharton Dr
Claremont, CA 91711 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
TECHNOLOGIST CHOICE TOURNIQUET2019-07-23
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Wooden Applicator2018-04-09
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice Wooden Applicator2018-04-09
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice Applicator, non-sterile, cotton tip, 6"2017-03-28
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Applicator, non-sterile, cotton tip, 6"2017-03-28
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
container, Specimen, Non-Sterile, Vacuum Urine Tube, Bio hazard Bags2017-03-22
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice zip lock bags, bio hazard bags2017-03-22
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (415)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (413)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (412)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (411)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (410)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (409)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (408)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (407)2017-03-14
Jason Gumaer [Advance Sentry Corporation]
NP Screen Specimen Collection Kit (406)2017-03-14
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Viba-Brush2014-10-29
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Evalyn Brush2014-10-29
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Anex Brush2014-10-29
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice Gauze Pads2014-02-26
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Gauze Pads2014-02-26
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Viba-Brush2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Viba-Brush RT2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers? Cervex-Brush? RT2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Cervex-Brush2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers? Cervex-Brush? Combi RT2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Cervex-Brush Combi2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Spatula2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers? EndoCervex-Brush?-S RT2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers? EndoCervex-Brush? RT2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers EndoCervex-Brush2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers EndoCervex-Brush-S2008-02-13
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Orcellex-Brush2007-08-14
Jason Gumaer [ROVERS MEDICAL DEVICES B.V.]
Rovers Orcellex-Brush RT2007-08-14
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice microscope slides2001-05-30
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Microscope slides2001-05-30
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Transfer Pipette2001-05-30
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Technologist Choice Transfer Pipette2001-05-30
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Urine container, Vacuum Tube1994-01-04
Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]
Container,Specimen, Sterile -Saturo, Technologist Choice Vacuum Urine Tube1994-01-04

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