Simpulse SOLO 0067690

GUDID 20801741010181

The Simpulse SOLO Wound Management Kit with VariCare Retractable Splash Shield Wound Tip

Davol Inc.

Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system Disposable surgical irrigation/aspiration system

• Primary Device ID: 20801741010181
• NIH Device Record Key: c231793b-7158-4700-9eae-1eeac1df1d89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpulse SOLO
• Version Model Number: 0067690
• Catalog Number: 0067690
• Company DUNS: 001191048
• Company Name: Davol Inc.
• 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: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com
• Phone: +1(800)562-0027
• Email: medical.services@crbard.com

Operating and Storage Conditions

• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 65 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741010187 [Primary]
GS1	10801741010184 [Package]; Contains: 00801741010187; Package: BX [5 Units]; In Commercial Distribution
GS1	20801741010181 [Package]; Contains: 10801741010184; Package: CA [2 Units]; In Commercial Distribution

FDA Product Code

• FQH: LAVAGE, JET

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-02-21
• Device Publish Date: 2015-12-23

On-Brand Devices [Simpulse SOLO]

• 20801741010181: The Simpulse SOLO Wound Management Kit with VariCare Retractable Splash Shield Wound Tip
• 10801741010177: The Simpulse SOLO System with Ultrex Retractable Splash Shield Tip
• 10801741010153: The Simpulse SOLO System with Ultrex Retractable 1-1/4" Splash Shield Tip
• 10801741010146: The Simpulse SOLO System with Showerhead Tip
• 10801741010139: The Simpulse SOLO System with Soft Splash Shield Tip
• 20801741010129: The Simpulse SOLO Suction/Irrigator
• 20801741000373: The Simpulse SOLO System with Ultrex Retractable Splash Shield Tip