NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691899190
• Version / Model: BC 140 Plus HEMOCONCENTRATOR
• Catalog Number: 70106.6552
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 6c0442a7-ced5-4c8c-bd5b-1143cde84416
• Distribution End Date: 2016-12-20

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KDI	Dialyzer, high permeability with or without sealed dialysate system	Gastroenterology, Urology	876.5860	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44602	Haemoconcentrator	A sterile filter intended to be used in the process of haemoconcentration (the concentration of blood elements by water and electrolyte removal) typically during treatment for fluid overload or during cardiac surgery involving extracorporeal circulation. It is typically an ultrafiltration filter contained within a closed cylindrical housing with connectors to an extracorporeal blood circuit and separate connectors for the removal of excess plasma water together with small plasma solutes (e.g., smaller than 50,000 Daltons); the haemoconcentrate is returned to the patient. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04037691899183	GS1		20	Not in Commercial Distribution	2016-12-20
Primary	04037691899190	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K123288	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			membrane surface area 1,35 Square meter 1,35 Square meter
Device Size Text, specify			cell sizes 1/2 Inch
Device Size Text, specify			priming volume 102 Milliliter