BBraun ASEPT 622273B

GUDID 10813623011240

ASEPT 1,000mL Bare Evacuated Drainage Bottle

PFM MEDICAL INCORPORATED

Closed-wound drainage reservoir suction bulb Closed-wound drainage reservoir suction bulb

• Primary Device ID: 10813623011240
• NIH Device Record Key: 3045b836-4e83-4244-ac24-fd51768007b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BBraun ASEPT
• Version Model Number: 622273B
• Catalog Number: 622273B
• Company DUNS: 097736867
• Company Name: PFM MEDICAL INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does n
• 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: 7607588749
• Email: customerservice@pfmmedicalusa.
• Phone: 7607588749
• Email: customerservice@pfmmedicalusa.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813623011243 [Primary]
GS1	10813623011240 [Package]; Contains: 00813623011243; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K001716

FDA Product Code

• JCX: Apparatus, Suction, Ward Use, Portable, Ac-Powered

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: 2016-09-29

On-Brand Devices [BBraun ASEPT]

• 10813623011257: ASEPT 600mL Bare Evacuated Drainage Bottle
• 10813623011240: ASEPT 1,000mL Bare Evacuated Drainage Bottle
• 10813623011219: ASEPT 2,000mL Drainage Bag with Procedure Pack
• 10813623011202: ASEPT 2,000mL Drainage Bag
• 10813623011196: ASEPT 1,000mL Evacuated Drainage Bottle without Drain Line
• 10813623011189: ASEPT 600mL Evacuated Drainage Bottle without Drain Line