Bio Nuclear Diagnostics Inc

FDA Filings

This page includes the latest FDA filings for Bio Nuclear Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 9680836
• FEI Number: 3005892511
• Name: Jason Gumaer
• Owner & Operator: BIO NUCLEAR DIAGNOSTICS, INC.
• Contact Address: 1791 ALBION RD. --; TORONTO, ONTARIO CA-NOTA M9W 5S7 CA
• Official Correspondent:
  • S. - CHOUDHRY
  • 01-416-6741545-x
• US Agent:
  • Jason Gumaer
  • Therapak
  • 909 2672091
  • jgumaer@therapak.com
• Importing Logistics Registration:
  • Importer: FUJIFILM SONOSITE MANUFACTURING,LLC
  • Address: 21919 30TH DRIVE SE ; Bothell, WA 98021 UNITED STATES
• Importing Logistics Registration:
  • Importer: WATAUGA HEALTHCARE
  • Address: 501 E WATAUGA AVE ; JC, TN 37601 UNITED STATES
  • Email Address: wataugahealthcarejc@gmail.com
  • Importer Type: END USER
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 651 Wharton Drive ; Claremont, CA 91711 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 10754013509988 Bio Nuclear Diagnostics Inc	Technologist Choice	2022-10-13
GUDID 10754013505478 Bio Nuclear Diagnostics Inc	Saturo	2022-09-22
GAX Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	TECHNOLOGIST CHOICE TOURNIQUET	2019-07-23
JRQ Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Wooden Applicator	2018-04-09
JRQ Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice Wooden Applicator	2018-04-09
KXF Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice Applicator, non-sterile, cotton tip, 6"	2017-03-28
KXF Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Applicator, non-sterile, cotton tip, 6"	2017-03-28
NNI Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	container, Specimen, Non-Sterile, Vacuum Urine Tube, Bio hazard Bags	2017-03-22
NNI Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice zip lock bags, bio hazard bags	2017-03-22
NAB Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice Gauze Pads	2014-02-26
NAB Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Gauze Pads	2014-02-26
PMN K081522 BIO NUCLEAR DIAGNOSTICS, INC.	BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY	2008-12-05
KEW Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice microscope slides	2001-05-30
KEW Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Microscope slides	2001-05-30
JRC Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Transfer Pipette	2001-05-30
JRC Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Technologist Choice Transfer Pipette	2001-05-30
FMH Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Urine container, Vacuum Tube	1994-01-04
FMH Jason Gumaer [BIO NUCLEAR DIAGNOSTICS, INC.]	Container,Specimen, Sterile -Saturo, Technologist Choice Vacuum Urine Tube	1994-01-04

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092636923	Shanghai ,China (Mainland) -> Tacoma, Washington	DISPOSABLE PROTECTIVE MASK(NON-MEDICAL)	1100 CTN
2020091815036	Tourane,Vietnam -> Tacoma, Washington	POLYBAG	2032 PKG
2020091864235	Shanghai ,China (Mainland) -> Seattle, Washington	NON WOVEN PAD	4100 CTN
2020091864553	Shanghai ,China (Mainland) -> Seattle, Washington	FACE MASKS	1100 CTN
2020091674001	Shanghai ,China (Mainland) -> Seattle, Washington	NON WOVEN PAD	4930 CTN
2020091261677	Shanghai ,China (Mainland) -> Seattle, Washington	NON WOVEN PAD	4930 CTN
2020091144695	Tourane,Vietnam -> Tacoma, Washington	POLYBAG	2032 PKG
2020090456273	Ningpo ,China (Mainland) -> Tacoma, Washington	FACE SHIELD	3008 CTN
2020090456273	Ningpo ,China (Mainland) -> Tacoma, Washington	FACE SHIELD	3008 CTN