3b Medical Inc

FDA Filings

This page includes the latest FDA filings for 3b Medical 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: 3009096682
• FEI Number: 3009096682
• Name: 3B MEDICAL, INC
• Owner & Operator: 3B Medical Inc.
• Contact Address: 203 Avenue A NW Winter Haven ; Winter Haven FL 33881 US
• Official Correspondent:
  • Yasser H Estafanous
  • 1-863-2266285-131
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 203 Avenue A NW Suite 300; Winter Haven, FL 33881 US
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K212263 3B Medical, Inc.	Luna G3 BPAP System	2022-03-25
GUDID 00860006339906 3B MEDICAL, INC.	Lumin	2021-02-09
PMN K201620 3B Medical, Inc.	Luna® G3 BPAP 25A	2021-01-29
PMN K200496 3B Medical Inc.	Aer X	2020-07-24
GUDID 00853041003000 3B MEDICAL, INC.	3B Medical Aer 021000M	2019-08-21
GUDID 00853041003819 3B MEDICAL, INC.	3B Medical, Inc	2018-07-06
GUDID 00853041003796 3B MEDICAL, INC.	3B Medical, Inc.	2018-07-06
GUDID 00853041003703 3B MEDICAL, INC.	3B Medical, Inc.'s Cirrus 5	2018-07-06
PMN K121260 | CAW 3B MEDICAL, INC [3B Medical Inc.]	3B Aer	2018-04-10
GUDID 00853041003970 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003956 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003949 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003932 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003925 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003901 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003895 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003871 3B MEDICAL, INC.	3B Medical, Inc	2018-03-29
GUDID 00853041003864 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003857 3B MEDICAL, INC.	3B Medical, Inc	2018-03-29
GUDID 00853041003840 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003833 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003826 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003802 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003642 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003635 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003628 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003611 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003543 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003369 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003277 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003260 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003253 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003246 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003239 3B MEDICAL, INC.	3B Medical, Inc	2018-03-29
GUDID 00853041003222 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003093 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003086 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00853041003079 3B MEDICAL, INC.	3B medical, inc.	2018-03-29
GUDID 00853041003048 3B MEDICAL, INC.	3B Medical, Inc.	2018-03-29
GUDID 00817783020251 3B MEDICAL, INC.	3B Medical, Inc. Qube Compressor Nebulizer	2018-03-29
LRJ 3B MEDICAL, INC [3B Medical Inc.]	Lumin	2018-01-25
LRJ 3B MEDICAL, INC [3B Medical Inc.]	Lumin Bullet	2018-01-25
PMN K160127 3B MEDICAL, INC.	ICodeConnect	2016-11-10
PMN K153387 3B MEDICAL, INC.	Luna CPAP And Auto CPAP System	2016-09-08
PMN K141770 3B MEDICAL, INC	LUNA CPAP AND AUTO-CPAP SYSTEM	2015-04-22
PMN K133769 3B MEDICAL, INC	3B RESMART BPAP 25A, BMC RESMART BPAP 25A	2014-08-25
PMN K131901 3B MEDICAL, INC	IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2	2013-12-23
PMN K132967 3B MEDICAL, INC	3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP	2013-12-06
PMN K131707 3B MEDICAL, INC	3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS	2013-08-22

Related Finance Registrations

NCAGE Code	7ZHH9	3B MEDICAL, INC.
CAGE Code	7ZHH9	3B MEDICAL, INC.

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020080561560	Pusan,South Korea -> Long Beach, California	1.NUMA FULL FACE MASK (BMC-FM2), 600S/3900M/8 00L 2.NUMA FULL FACE MASK REPLACEMENT CUSHION ,600S/2900M/1700L 3.SIESTA NASAL MASK (N5B)-A LL SIZE KIT 4.SIESTA NASAL MASK (N5B), 2500S/ 2500M/2500L 5.RIO II NASAL PILLOWS INTERFACE (P2)-ALL SIZE KIT	1561 CTN
2020073039969	Pusan,South Korea -> Long Beach, California	1. F2 SINGLE-PATIENT VENTED FULL FACE MASK( BMC-FM2 )-SMALL 2. NUMA FULL FACE MASK ( BMC-FM2 )-500S 1000M 500L 3. NUMA FULL FACE MASK REPLACEMENT CUSHION-LARGE 4. RIO II NASAL PILLOWS INTERFACE( P2 )-ALL	1144 CTN
2020041429366	Yantian,China (Mainland) -> Long Beach, California	LUMIN UV CLEANER	1100 CTN
2020041429366	Yantian,China (Mainland) -> Long Beach, California	LUMIN UV CLEANER	1100 CTN
2020040738357	Shanghai ,China (Mainland) -> Los Angeles, California	ADULT CPAP TUBE THIS SHIPMENT CONTAINS NO WOOD PACKING MATERIALS	600 CTN
2020040648240	Yantian,China (Mainland) -> Los Angeles, California	LUMIN UV CLEANER	550 CTN
2020032613641	Pusan,South Korea -> Long Beach, California	OXYGEN CONCENTRATOR CONTRACT NUMBER: SYS-PO-19263	615 CTN
202003185941	Tsingtao,China (Mainland) -> Los Angeles, California	OXYGEN CONCENTRATOR	615 CTN
2020022024814	Pusan,South Korea -> Long Beach, California	CPAP AUTO CPAP	2100 CTN