ASEPT Pleural Drainage System M7001

GUDID 10813623017013

ASEPT Pleural Drainage System

PFM MEDICAL INCORPORATED

Pleural/peritoneal drainage catheterization kit

• Primary Device ID: 10813623017013
• NIH Device Record Key: 48ca3f29-2643-43d7-8aff-d12c2c857831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASEPT Pleural Drainage System
• Version Model Number: M7001
• Catalog Number: M7001
• Company DUNS: 097736867
• Company Name: PFM MEDICAL 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: true
• Device Combination Product: true
• 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: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623017016 [Primary]
GS1	10813623017013 [Package]; Contains: 00813623017016; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093307

FDA Product Code

• DWM: Apparatus, Suction, Patient Care

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-06
• Device Publish Date: 2016-10-02

On-Brand Devices [ASEPT Pleural Drainage System]

• 10813623017013: ASEPT Pleural Drainage System
• 10813623011356: ASEPT Pleural Drainage System
• 10813623011165: ASEPT Pleural Drainage System