Southmedic Inc

FDA Filings

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

FDA Registration(s)
Registration Number3008567560
FEI Number3008567560
NameSouthmedic Inc.
Owner & OperatorJBS Logistic & Warehousing
Contact Address2043 Corporate Lane
Naperville IL 60563 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address2043 Corporate Lane
Naperville, IL 60563 US



Registration Number8022032
FEI Number3001717360
NameSOUTHMEDIC, INC.
Owner & OperatorSOUTHMEDIC, INC.
Contact Address50 ALLIANCE BLVD., --
BARRIE CA-ON Ontario L4M 5K3 CA
US Agent
Importing Logistics Registration
ImporterAmerican Mail Order Pharmacy Inc.
Address23290 Schoenherr Road
Warren, MI 48089 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address50 ALLIANCE BLVD.,
BARRIE Ontario, L4M 5K3 CA
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device for Another Party (Contract Manufacturer)



FDA Filings

Device
Company
DeviceDate
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OP-2125-14SLM2024-02-05
Southmedic Incorporated
Oxy2Pro PRM-2110-MDT2023-12-11
Southmedic Incorporated
Oxy2Pro PRM-2110-8M2023-12-11
Southmedic Incorporated
Oxy2Pro PRM-2110-8F2023-12-11
Southmedic Incorporated
Oxy2Pro PRP-2110-MDT2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OP-2125-MDT2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OP-2125-142023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OP-2125-8SLM2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OM-2125-MDT2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OM-2125-14SLM2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OM-2125-142023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OM-2125-8SLM2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OK-2125-MDT2023-12-11
Southmedic Incorporated
Oxy2Mask O2/EtCO2 OK-2125-8SLM2023-12-11
Southmedic Incorporated
Oxy2Pro PRP-2110-8M2023-12-11
Southmedic Incorporated
Oxy2Pro PRP-2110-8F2023-12-11
Southmedic Incorporated
Bite Block ETPSR3-00A502023-07-03
Southmedic Incorporated
Bite Block ETPSR-00P502023-07-03
Southmedic Incorporated
Bite Block ETPSR-00A502023-07-03
Southmedic Incorporated
OxyMulti-Mask™ OPHH-1025-8S2023-03-08
Southmedic Incorporated
OxyMulti-Mask™ OHH-1025-8S2023-03-08
Southmedic Incorporated
OxyMulti-Mask™ OKHH-1025-8S2023-03-08
Southmedic Incorporated
Oxy2Mask™ OP-1425-82023-03-08
Southmedic Incorporated
Oxy2Mask™ OM-1425-82023-03-08
Southmedic Incorporated
Oxy2Mask™ OP-1125-142023-03-08
Southmedic Incorporated
Oxy2Mask™ OM-1125-142023-03-08
Southmedic Incorporated
Oxy2Mask™ OK-1125-142023-03-08
Southmedic Incorporated
SPSS Safety Scalpel Metal Handle 73-8071-12023-02-15
Southmedic Incorporated
SPSS Safety Scalpel Metal Handle 73-8041-12023-02-15
Southmedic Incorporated
SPSS Safety Scalpel Metal Handle 73-8040-12023-02-15
Southmedic Incorporated
SPSS Safety Scalpel Metal Handle 73-8031-12023-02-15
Southmedic Incorporated
SPSS Safety Scalpel Metal Handle 73-8030-12023-02-15
Southmedic Incorporated
EcoZyme 27545-042022-11-29
Southmedic Incorporated
EcoZyme 27545-082022-09-07
Southmedic Incorporated
EcoSonic 43394-042022-09-07
Southmedic Incorporated
EcoZyme 27545-322022-09-07
Southmedic Incorporated
EcoZyme 27545-162022-09-07
Southmedic Incorporated
EcoZyme Ultra 18560-2.52022-09-07
Southmedic Incorporated
EcoZyme Ultra 18560-152022-09-07
Southmedic Incorporated
EcoZyme Ultra 18560-052022-09-07
Southmedic Incorporated
EcoZyme Ultra 18560-042022-09-07
Southmedic Incorporated
EcoZyme Auto 17560-2.52022-09-07
Southmedic Incorporated
EcoZyme Auto 17560-052022-09-07
Southmedic Incorporated
EcoZyme Auto 17560-042022-09-07
Southmedic Incorporated
EcoBase 11050-2.52022-09-07
Southmedic Incorporated
EcoBase 11050-152022-09-07
Southmedic Incorporated
EcoBase 11050-052022-09-07
Southmedic Incorporated
EcoBase 11050-042022-09-07
Southmedic Incorporated
OxyMask™ II OT-7025-82022-06-14
Southmedic Incorporated
OxyMask™ II OK-7025-82022-06-14
Southmedic Incorporated
OxyMask™ II OP-7025-82022-06-14
Southmedic Incorporated
OxyMask™ II OM-7025-82022-06-14
Southmedic Incorporated
OxyMask™ II OT-1025-82022-06-14
Southmedic Incorporated
OxyMask™ II OK-1125-82022-06-14
Southmedic Incorporated
OxyMask™ II OP-1125-82022-06-14
Southmedic Incorporated
OxyMask™ II OM-1125-82022-06-14
Southmedic Incorporated
OxyMask™ II OP-2125-82022-06-14
Southmedic Incorporated
OxyMask™ II OM-2125-82022-06-14
Southmedic Incorporated
OxyMask™ II OK-2125-82022-06-14
Southmedic Incorporated
SMDIA-1300 SMDIA-13002022-06-10
Southmedic Incorporated
SMDIA-1200 SMDIA-12002022-06-10
Southmedic Incorporated
SMDIA-1100 SMDIA-11002022-06-10
Southmedic Incorporated
SMDIA-1000 SMDIA-10002022-06-10
Southmedic Incorporated
Capnoxygen® CO2-04-SLM-142022-05-26
Southmedic Incorporated
Capnoxygen® CO2-04-142022-05-26
Southmedic Incorporated
Capnoxygen® CO2-03-142022-05-26
Southmedic Incorporated
Capnoxygen® CO2-01-142022-05-26
Southmedic Incorporated
OxyMulti-Mask™ OPHH-1425-82022-05-26
Southmedic Incorporated
NCP-2025-8 NCP-2025-82022-03-22
Southmedic Incorporated
NC-2025-8F NC-2025-8F2022-03-22
Southmedic Incorporated
CO2SL055-8MM CO2SL055-8MM2022-03-22
Southmedic Incorporated
CO2SL055-8MF CO2SL055-8MF2022-03-22
Southmedic Incorporated
NC-2025-7 NC-2025-72022-03-22
Southmedic Incorporated
NC-2025-8 NC-2025-82022-03-22
Southmedic Incorporated
NC-2025-14 NC-2025-142022-03-22
Southmedic Incorporated
Dynamic Tissue Systems™ CZE072020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DCNE-022020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DCNE-012020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DCX202020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DCX102020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DSX382020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DSX242020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DWC382020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DWC242020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DWS142020-12-28
Southmedic Incorporated
Dynamic Tissue Systems™ DWS122020-12-28
Southmedic Incorporated
OxyPlus™ OP-1125-142020-12-28
Southmedic Incorporated
OxyPlus™ OP-1125-82020-12-28
Southmedic Incorporated
OxyMask™ OM-7025-82020-12-28
Southmedic Incorporated
OxyMask™ OM-1425-82020-12-28
Southmedic Incorporated
OxyMask™ OM-1125-142020-12-28
Southmedic Incorporated
OxyMask™ OM-1125-82020-12-28
Southmedic Incorporated
OxyKid™ OK-7025-82020-12-28
Southmedic Incorporated
OxyKid™ OK-1125-142020-12-28
Southmedic Incorporated
OxyKid™ OK-1125-82020-12-28
Southmedic Incorporated
OxyArm™ OA-PLUS-3125-82020-12-28
Southmedic Incorporated
OxyArm™ OA-PLUS-1125-82020-12-28
Southmedic Incorporated
OxyArm™ OA-HB-11252020-12-28
Southmedic Incorporated
OxyArm™ OA-DA-30252020-12-28
Southmedic Incorporated
OxyArm™ OA-DA-10252020-12-28
SOUTHMEDIC, INC.
CRH O'Regan Hemorrhoid Ligator2019-12-06
SOUTHMEDIC, INC.
CRH O'Regan Hemorrhoid Ligator with Integrated Obturator2019-12-06
SOUTHMEDIC, INC.
Oragene Dx OGD-510, OGD-600, OGD-610, OGD-6752019-07-10
SOUTHMEDIC, INC.
FLUSSO BY-PASS ADAPTER2019-04-24
SOUTHMEDIC, INC.
Flex, Softcup, Softdisc2018-08-28
SOUTHMEDIC, INC.
ABRA Surgical Skin Closure2017-11-06
SOUTHMEDIC, INC.
ABRA Adhesive Skin Closure2017-11-06
SOUTHMEDIC, INC.
ABRA Abdominal Closure2017-11-06
SOUTHMEDIC, INC.
SurgiFish2017-08-15
SOUTHMEDIC, INC.
Southmedic Surgical Retainer2017-08-15
SOUTHMEDIC, INC.
Southmedic Scalpel Handle2014-04-07
SOUTHMEDIC, INC.
DynaCleft2014-03-31
SOUTHMEDIC, INC.
DynaCleft Nasal Elevator2014-03-31
SOUTHMEDIC, INC.
SutureSafe2014-03-31
SOUTHMEDIC, INC.
DynaStretch2014-03-31
SOUTHMEDIC, INC.
DynaClose2014-03-31
SOUTHMEDIC, INC.
Cannulator2014-03-31
SOUTHMEDIC, INC.
ABRA Loop Cannulator2014-03-31
SOUTHMEDIC, INC.
Chess Surgery System2014-03-31
SOUTHMEDIC, INC.
CD Labs System2014-03-31
SOUTHMEDIC, INC.
ABRA DTS Silicone Elastomer Cord2014-03-31
SOUTHMEDIC, INC.
ABRA DTS Elastomer Retainer2014-03-31
SOUTHMEDIC, INC.
ABRA DTS Button Tails2014-03-31
SOUTHMEDIC, INC.
ABRA Abdominal 3 Row Pack2014-03-31
SOUTHMEDIC, INC.
CO2/O2 Sampling line2014-01-15
SOUTHMEDIC, INC.
CO2/O2 Nasal Cannula2014-01-15
SOUTHMEDIC, INC.
CO2/O2 NASAL CANNULA (WITH 4 (10CM) O2 AND CO2 TUBE), CO2/O2 NASAL CANNULA (WITH 8 (240CM) O2 AND 4 (10CM) CO2 TUBE),2014-01-13
SOUTHMEDIC, INC.
Capnoxygen Mask2012-05-10
SOUTHMEDIC, INC.
Clear Choice Eye and Face Shields and Frames2012-01-17
SOUTHMEDIC, INC.
BetterShield2012-01-17
SOUTHMEDIC, INC.
Vapofil2012-01-11
SOUTHMEDIC, INC.
Quik Fil2012-01-11
SOUTHMEDIC, INC.
AntiSpil2012-01-11
SOUTHMEDIC, INC.
Multi Dose Inhaler Adapter2011-02-14
SOUTHMEDIC, INC.
SMDIA-10002011-01-07
SOUTHMEDIC, INC.
Southmedic Blades and Scalpels2008-12-22
SOUTHMEDIC, INC.
Lancet2008-12-22
SOUTHMEDIC, INC.
Vaporizer Spacer2008-02-12
SOUTHMEDIC, INC.
Vapofil2008-02-12
SOUTHMEDIC, INC.
Foam Headrest2008-02-12
SOUTHMEDIC, INC.
Bite Block2007-12-04
SOUTHMEDIC, INC.
Oxykid Nebulizer Kit2007-04-12
SOUTHMEDIC, INC.
OxyTyke Nebulizer Kit2007-04-12
SOUTHMEDIC, INC.
OxyPlus Nebulizer Kit2007-04-12
SOUTHMEDIC, INC.
OxyMask Adult Nebulizer Kit2007-04-12
SOUTHMEDIC, INC.
OxyPlus ETCO2 Mask2006-07-31
SOUTHMEDIC, INC.
OxyMask CO2 various2006-07-31
SOUTHMEDIC, INC.
OxyMask Adult ETCO22006-07-31
SOUTHMEDIC, INC.
OxyKid ETCO2 Mask2006-07-31
SOUTHMEDIC, INC.
OxyArm ETCO22006-07-31
SOUTHMEDIC, INC.
STERILIZATION TRAYS2006-03-14
SOUTHMEDIC, INC.
SOUTHMEDIZYME EP2006-03-14
SOUTHMEDIC, INC.
OXYTUBE2006-03-14
SOUTHMEDIC, INC.
OXYARM CO22002-06-11
SOUTHMEDIC, INC.
OxyArm Nasal Cannula2002-01-09
SOUTHMEDIC, INC.
Nasal Cannula2002-01-09
SOUTHMEDIC, INC.
OxyTyke1998-10-15
SOUTHMEDIC, INC.
OxyTrach1998-10-15
SOUTHMEDIC, INC.
OxyMulti Mask1998-10-15
SOUTHMEDIC, INC.
OxyMask Ultra1998-10-15
SOUTHMEDIC, INC.
OxyMask OxyKid OxyPlus1998-10-15
SOUTHMEDIC, INC.
OxyChin1998-10-15
SOUTHMEDIC, INC.
OxyArm1998-10-15
SOUTHMEDIC, INC.
Oxy Aerosol Mask1998-10-15
SOUTHMEDIC, INC.
VAPOFIL1995-02-22
SOUTHMEDIC, INC.
FUNNEL ADAPTOR1993-03-18
SOUTHMEDIC, INC.
AEROSOL-T1986-09-11
SOUTHMEDIC, INC.
VAPOFIL1986-05-21
SOUTHMEDIC, INC.
VAPORIZER SPACER1986-04-17
SOUTHMEDIC, INC.
ANAESLOCK THREE VAPORIZER INTERLOCK HVA0031984-11-15

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020072049331Vancouver, BC ,Canada -> Long Beach, CaliforniaOXYGEN DELIVERY DEVICE INV 560426 ORDER S473199 PO 807904 POR CAED 01A503UC160220200600091 HS/NCM 9019201 PCS
2020072049599Vancouver, BC ,Canada -> Long Beach, CaliforniaOXYGEN DELIVERY DEVICE INV 560426 ORDER S473199 PO 807904 CAED 01A503UC160220200600091 HS-CODE 9019201 PKG
2018073053083Tsingtao,China (Mainland) -> Tacoma, WashingtonPLASTIC PACKAGING BAGS43 CTN
2018040934598Tsingtao,China (Mainland) -> Tacoma, WashingtonPLASTIC PACKAGING BAGS64 CTN
2018032628208Anvers,Belgium -> Norfolk, VirginiaUNDERWATER OXYGEN BAR SYSTEM NOS OX11 PKG
2018030229625Anvers,Belgium -> Norfolk, VirginiaUNDERWATER OXYGEN BAR SYSTEM NOS OX12 PKG
2018012629919Tsingtao,China (Mainland) -> Tacoma, WashingtonPLASTIC PACKAGING BAGS 2319-A 74CTNS=2PALLETS74 CTN

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