NA

Basic Information

• Brand Name: NA
• Primary DI: 04037691572758
• Version / Model: Pediatric Venous Hardshell Reservoir
• Catalog Number: 70104.8595
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-24
• Public Version: 4
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 26e85659-5d08-4d26-85ba-59abd19058b7

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
DTP	Defoamer, cardiopulmonary bypass	Cardiovascular	870.4230	2
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
Primary	04037691572758	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K141432	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			pore size cardiotomy volume filter 40 micrometer
Pore Size	64	Micrometer
Total Volume	1700	Milliliter
Device Size Text, specify			connector size blood outlet 1/4 Inch
Device Size Text, specify			connector size blood inlet 3/8 Inch
Device Size Text, specify			minimum operating volume 30 milliliter