Simpulse Plus 0057570

GUDID 20801741065259

Simpulse Plus Suction/Irrigator

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: 20801741065259
• NIH Device Record Key: 545735cc-ae9d-4088-8e3b-f73c2bb77fe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Simpulse Plus
• Version Model Number: 0057570
• Catalog Number: 0057570
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741065255 [Primary]
GS1	10801741065252 [Package]; Contains: 00801741065255; Package: BX [5 Units]; In Commercial Distribution
GS1	20801741065259 [Package]; Contains: 10801741065252; 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 Plus]

• 10801741065283: Simpulse PLUS System with Ultrex Retractable Splash Shield Tip (1.75" diameter) Tip, Suction Tub
• 10801741065276: Simpulse Plus System with Showerhead Tip, Suction Tubing, and Dual Spike Adapter
• 10801741065269: Simpulse Plus System with Soft Splash Shield Tip, Suction Tubing, and Dual Spike Adapter
• 20801741065259: Simpulse Plus Suction/Irrigator