FREUDENBERG MEDICAL, LLC

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

• freudenbergmedical.com
• inhealth.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• FirstFit Surgical Kit

  2024-12-18

  Freudenberg Medical, LLC

• Steerable Introducer 12F

  2019-10-04

  Freudenberg Medical LLC

• Steerable Introducer

  2019-08-01

  Freudenberg Medical LLC

• FlexSeal Introducer Sheath With Hydrophilic Coating

  2019-05-30

  Freudenberg Medical MIS, Inc

GUDID#

• InHealth Technologies; Blom-Singer - BE 6050

  Freudenberg Medical, LLC

  2017-01-01

• InHealth Technologies; Blom-Singer - BE 2050

  Freudenberg Medical, LLC

  2017-01-01

• InHealth Technologies; Blom-Singer - BE 6036

  Freudenberg Medical, LLC

  2017-01-01

• InHealth Technologies; Blom-Singer - BE 2036

  Freudenberg Medical, LLC

  2017-01-01

• InHealth Technologies; Blom-Singer - BE 2051

  Freudenberg Medical, LLC

  2017-01-01

• InHealth Technologies; Blom-Singer - BE 2052

  Freudenberg Medical, LLC

  2017-01-01

• EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING - The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

  FREUDENBERG MEDICAL, LLC

  2026-01-29

• EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING - The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable introducer sheath and dilator that is inserted into the peripheral vasculature to support the introduction of diagnostic or interventional devices, while minimizing blood loss associated with such insertions. The EMPOWER™ Introducer Sheath is coil-reinforced and coated with a lubricious hydrophilic coating. The EMPOWER™ hemostasis valve is integrated into the sheath hub and features a variable aperture seal for enhanced control over device insertion while maintaining hemostasis. The valve is normally closed until the user squeezes the actuator levers to proportionally open the valve and receive any device up to its labeled size. A sideport extends from the EMPOWER™ valve housing with a 3-way stopcock. The radiopaque dilator is designed to accommodate an .035” (0.89mm) guidewire and includes a proximal hub grip with a female luer taper fitting for flushing. Prior to insertion, the dilator hub can be secured to the EMPOWER™ housing with a quarter-turn twist.

  FREUDENBERG MEDICAL, LLC

  2021-06-15

• Steerable Introducer Sheath 12F - The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

  FREUDENBERG MEDICAL, LLC

  2020-01-13

• Steerable Introducer Sheath 8.5F Small Curl - The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

  FREUDENBERG MEDICAL, LLC

  2019-10-25

• Steerable Introducer Sheath 8.5F Medium Curl - The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

  FREUDENBERG MEDICAL, LLC

  2019-10-25

• Steerable Introducer Sheath 8.5F Large Curl - The Steerable introducer sheath consists of a steerable sheath connected to a handle with steering controls, a hemostasis valve with sideport featuring a 3-way stopcock, and a tapered dilator. The device is provided sterile in a sealed tyvek pouch and carton with IFU. The sheath distal tip and dilator shaft are radiopaque for visualization under fluoroscopy. The dilator is designed to accommodate a guidewire, with size compatibility as indicated on the product labels. A dilator hub is provided with a female luer tapered fitting for flushing. The device includes a side port with stopcock to allow fluid injection and sampling, drip infusion, pressure monitoring, flushing and aspiration. The device usable length, lumen length, outer diameter, curl size, and inner diameter/tool compatibility specifications are indicated on the product labels. The distal end of the sheath features 180° bi-directional deflection to provide directional control to the compatible tools interacting with the device.

  FREUDENBERG MEDICAL, LLC

  2019-10-25

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME

  Freudenberg Medical, LLC

  2019-07-10

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 12/55 Tube & EasyFlow HME

  Freudenberg Medical, LLC

  2019-07-10

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 9/55 Tube & ClassicFlow HME

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 9/55 Tube & EasyFlow HME

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 10/55 Tube & EasyFlow HME

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis

  Freudenberg Medical, LLC

  2019-06-07

• InHealth Technologies; Blom-Singer - BE 6045

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6046

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6041

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6042

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6043

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6044

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6034

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6035

  Freudenberg Medical, LLC

  2018-01-01

• InHealth Technologies; Blom-Singer - BE 6048

  Freudenberg Medical, LLC

  2016-09-24

• StomaSoft Cleaning Swabs - The StomaSoft Cleaning Swabs are intended for cleaning tubes after removal from the patient.

  Freudenberg Medical, LLC

  2025-03-17

• TruFit™ Adhesive Housing, 6 Pack - BE 6088-6

  Freudenberg Medical, LLC

  2025-04-01

• TruFit™ Adhesive Housing, 30 Pack - BE 6088

  Freudenberg Medical, LLC

  2025-04-01

• TruFit™ Adhesive Housing, 30 Pack - BE 6088

  Freudenberg Medical, LLC

  2025-04-01

• Cleaning Brush, Standard - IN 4062

  Freudenberg Medical, LLC

  2025-03-25

• Cleaning Brush, Long - IN 4063

  Freudenberg Medical, LLC

  2025-03-25

• InHealth Technologies; Blom-Singer - BE 1080

  Freudenberg Medical, LLC

  2017-01-01

• Blom-Singer® Nasal Septal Perforation Sizing Tool - The Nasal Septal Perforation Sizing Tool (NSPST) is a graded handheld device designed to measure nasal septal perforations. The device is available in oval and round configurations with gradations that coincide with the offered sizes of Blom-Singer® Nasal Septal Perforation Prostheses. The device provides a method for measurement of size and thickness of nasal perforations to aid in selection of the appropriate Blom-Singer® Nasal Septal Perforation Prosthesis. The NSPST is a single use, non-sterile, disposable, invasive, transient duration (<60mins) measuring accessory to the Blom-Singer Nasal Septal Perforation Prosthesis. Each will be packed in a sealed pouch, 5 sealed pouches in one carton box which is sold as 1 unit of SPT 002.

  Freudenberg Medical, LLC

  2025-03-14

• InHealth Technologies; Blom-Singer - Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 8mm length

  Freudenberg Medical, LLC

  2023-11-03

• InHealth Technologies; Blom-Singer® - Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 10mm length

  Freudenberg Medical, LLC

  2023-11-03

• InHealth Technologies; Blom-Singer® - Blom-Singer® FirstFit Surgical Kit with 16Fr Classic Indwelling Voice Prosthesis, 12mm length

  Freudenberg Medical, LLC

  2023-11-03

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