EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING PN1007960-100

GUDID 00198715836998

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

Vascular dilator, single-use

• Primary Device ID: 00198715836998
• NIH Device Record Key: 458d91bd-7677-4f65-a561-9c2d0ff796ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING
• Version Model Number: 668782-101
• Catalog Number: PN1007960-100
• Company DUNS: 790487263
• Company Name: FREUDENBERG MEDICAL, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com
• Phone: 812-280-2400
• Email: DL-Corp-UniqueDeviceIndicator@freudenbergmedical.com

Device Dimensions

• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter
• Catheter Gauge: 21 French
• Catheter Working Length: 56 Centimeter
• Guidewire Diameter: 0.035 Inch
• Lumen/Inner Diameter: 7 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.
• Special Storage Condition, Specify: Between 0 and 0 *Store at room temperature in a dark, dry place to avoid extended exposure to light and moisture.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00198715836998 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190628

FDA Product Code

• DYB: Introducer, Catheter

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

[00198715836998]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-06
• Device Publish Date: 2026-01-29

On-Brand Devices [EMPOWER™ INTRODUCER SHEATH WITH HYDROPHILIC COATING]

• 00850004312001: The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable in
• 00198715836998: The EMPOWER™ Introducer Sheath with Hydrophilic Coating consists of a single-use disposable in