PLEUR EVAC A-8020-08LF

GUDID 44026704428869

PE INFANT WET LF

TELEFLEX INCORPORATED

Pleural drainage system

• Primary Device ID: 44026704428869
• NIH Device Record Key: 189e1e2e-7576-4a17-b50e-7b9c5a02adaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PLEUR EVAC
• Version Model Number: IPN010610
• Catalog Number: A-8020-08LF
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Dimensions

• Width: 6.5 Inch
• Total Volume: 150 Milliliter
• Length: 16.5 Inch
• Depth: 2.5 Inch
• Width: 6.5 Inch
• Total Volume: 150 Milliliter
• Length: 16.5 Inch
• Depth: 2.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	34026704428862 [Primary]
GS1	44026704428869 [Package]; Contains: 34026704428862; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K905768

FDA Product Code

• KDQ: BOTTLE, COLLECTION, VACUUM

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: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [PLEUR EVAC]

• 44026704428869: PE INFANT WET LF
• 44026704428852: PE ADULT-PED WET DUAL COLL LF
• 44026704428845: PE ADULT-PED WET LF
• 44026704428821: PE ADULT-PED WET LF
• 44026704428814: PE DRY/WET LF PREMATED ATS
• 44026704428807: PE DRY/WET DUAL COLL LF
• 44026704428791: PE ADULT-PED DRY/ WET LF
• 44026704428784: Pneumonectomy Drain
• 44026704411120: PE INFANT DRY/WET LF
• 44026704410833: PE ADULT-PED WET DUAL COLL LF
• 44026704410093: PE ADULT-PED WET LF ENG/SPANISH
• 44026704410086: PE ADULT-PED WET LF INTL ENG