NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691740348
• Version / Model: Venous Reservoir Bag 800 ml
• Catalog Number: 70105.4265
• 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: 6
• Public Version Date: 2020-02-03
• Public Version Status: Update
• Public Device Record Key: aa732453-ae29-4fab-970a-15434830d339
• Distribution End Date: 2020-02-01

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
DTN	RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS	Cardiovascular	870.4400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
31710	Cardiotomy reservoir	A device intended to be integrated within an extracorporeal circuit to collect, store, and filter blood typically during a cardiopulmonary bypass procedure; it does not include additional functional components such as an oxygenator. It is typically a hardshell or soft, bag-like container with connectors designed to trap micro-particles and air bubbles for a period of time (e.g., 6 hours) and hold a reserve supply of blood; some types may also defoam. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	04037691740331	GS1		10	Not in Commercial Distribution	2020-02-01
Primary	04037691740348	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K090690	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			connector size outlet 3/8 Inch
Total Volume	800	Milliliter
Device Size Text, specify			maximum blood flow6,5 [l/min]
Pore Size	185	Micrometer
Device Size Text, specify			connector size cardiotomy outlet 3/8 Inch
Device Size Text, specify			connector size venous inlet 1/2 Inch