ASEPT M7004

GUDID 20813623017041

ASEPT Replacement Valve

PFM MEDICAL INCORPORATED

Pleural drainage valve

• Primary Device ID: 20813623017041
• NIH Device Record Key: a06b6fc7-6af7-43b5-b471-a15d1a47d089
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASEPT
• Version Model Number: M7004
• Catalog Number: M7004
• 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: 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: 760-758-8749
• Email: customerservice@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623017047 [Primary]
GS1	10813623017044 [Package]; Contains: 00813623017047; Package: [5 Units]; In Commercial Distribution
GS1	20813623017041 [Package]; Contains: 10813623017044; Package: [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093796

FDA Product Code

• PNG: Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-04-08
• Device Publish Date: 2019-03-31

On-Brand Devices [ASEPT]

• 10813623017020: ASEPT 600mL Drainage Kit
• 10813623016986: ASEPT 1,000mL Starter Kit
• 10813623016979: ASEPT 600mL Starter Kit
• 10813623015743: ASEPT 600mL Drainage Bottle with Y-Site Drain
• 00813623012066: ASEPT 1000mL Drainage Bottle with Y-Site Drain
• 20813623011384: ASEPT Procedure Pack
• 20813623017058: ASEPT Drainage Line Set
• 20813623017041: ASEPT Replacement Valve