ASEPT M7050

GUDID 00813623012066

ASEPT 1000mL Drainage Bottle with Y-Site Drain

PFM MEDICAL INCORPORATED

Pleural/peritoneal drainage catheterization kit

• Primary Device ID: 00813623012066
• NIH Device Record Key: 4c0ea63e-9626-442f-aae0-fab41bd6f8b1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASEPT
• Version Model Number: M7050
• Catalog Number: M7050
• Company DUNS: 097736867
• Company Name: PFM MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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: 7607588749
• Email: regulatory@pfmmedicalusa.com
• Phone: 7607588749
• Email: regulatory@pfmmedicalusa.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623012066 [Primary]
GS1	10813623012063 [Package]; Package: [10 Units]; In Commercial Distribution

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: 2019-09-05
• Device Publish Date: 2016-10-05

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