12th Man Technologies Inc

FDA Filings

This page includes the latest FDA filings for 12th Man Technologies Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

12th Man Technologies Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3009108174
FEI Number3009108174
Name12TH MAN TECHNOLOGIES INC
Owner & Operator12th Man Technologies Inc
Contact Address7245 Garden Grove Blvd. Suite C
Garden Grove CA 92841 US
Official Correspondent
  • Alex Stenzler
  • x-714-7054576-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address7245 GARDEN GROVE BLVD STE C
Garden Grove, CA 92841 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
12TH MAN TECHNOLOGIES INC
Hi-Ox?2017-12-02
12TH MAN TECHNOLOGIES INC
Hi-Ox? High Oxygen Mask2017-12-02
12TH MAN TECHNOLOGIES INC
Hi-Ox2017-12-02
12TH MAN TECHNOLOGIES INC
BRX PRO2016-03-26
12TH MAN TECHNOLOGIES INC
BRO PRO Mouthguard2016-03-26
12TH MAN TECHNOLOGIES INC
BigEasy Non-Rebreathing Valve2016-03-26
12TH MAN TECHNOLOGIES INC
GoSpiro Mouthport Adapter2016-03-09
12TH MAN TECHNOLOGIES INC
Parallel2016-03-09
12TH MAN TECHNOLOGIES INC
Parallel-R2016-03-09
12TH MAN TECHNOLOGIES INC
Parallel-R Nose Clip2016-03-09
12TH MAN TECHNOLOGIES INC
Parallel Nose Clip2016-03-09
12TH MAN TECHNOLOGIES, INC.
BRX PRO Bruxism Guard2015-12-10
12TH MAN TECHNOLOGIES INC
Medical Device Data System - VitaCast2015-08-30
12TH MAN TECHNOLOGIES INC
Medical Device Data System - GoHome2015-08-30
12TH MAN TECHNOLOGIES INC
Medical Device Data System - CareConnect2015-08-30
12th Man Technologies, Inc.
BigEasy Non-Rebreathing Valve2015-03-23
12TH MAN TECHNOLOGIES INC
BIGEASY MASK2014-08-19
12TH MAN TECHNOLOGIES INC
NEOR Mask Adapter2011-05-12

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
202005142920Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726; 510K: K142402.200 CTN
202002183065Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402. BIGE ASY MASK ONLY. FDA LISTING NO.: D271728200 CTN
2019102412294Yantian,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402.200 CTN
201903133699Shekou,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726. 510K: K142402400 CTN
201901294519Shekou,China (Mainland) -> Jacksonville, FloridaBIGEASY MASK AND VALVE KIT. FDA LISTING NO. : D271728 AND D271726; 510K: K142402. BIGE ASY MASK ONLY. FDA LISTING NO.: D271728200 CTN
201809224557Shekou,China (Mainland) -> Jacksonville, Florida10PCS IN ONE PRINTED BOX AND 8 PRINTED BOXE S IN ONE OUTER BOX. BIGEASY MASK AND VALVE KIT. FDA LISTING NO.: D271728 AND D271726. 510K: K142402.200 CTN
2018070744060Hong Kong,Hong Kong -> Long Beach, CaliforniaITEM: MASK 663 CARTONS PACKING INTO 2PLTS663 CTN
2018051751777Hong Kong,Hong Kong -> Long Beach, CaliforniaITEM: 3D N95 MASK425 CTN

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