VHK Venous Reservoir

Basic Information

• Brand Name: VHK Venous Reservoir
• Primary DI: 04037691838663
• Version / Model: BO-VHK 71000, Adult, SOFTLINE, Sterile
• Catalog Number: 70106.3858
• Company Name: Maquet Cardiopulmonary AG
• Labeler DUNS: 316153865
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-13
• Public Version: 5
• Public Version Date: 2020-11-20
• Public Version Status: Update
• Public Device Record Key: 58505be2-1c22-4383-b59b-d0029e3a7d47
• Distribution End Date: 2020-11-12

Device Description

Venous Hardshell Cardiotomy Reservoir, Adult, Vacuum-tight, with SOFTLINE Coating, without screw connector, Sterile. The Venous Hardshell Cardiotomy Reservoirs are developed for the use in the field cardiopulmonary bypass operation. They are used as blood buffer in the extracorporeal circuit and as collecting and defoaming device for sucked blood. The vacuum-tight version of the VHK reservoir (VHK 71000) can also be employed postoperatively as drainage and auto-transfusion reservoir (e.g., for thorax drainage) to return the autologous blood to the patient which was removed from the thorax for the volume exchange.

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
JOD	FILTER, BLOOD, CARDIOTOMY SUCTION LINE, CARDIOPULMONARY BYPASS	Cardiovascular	870.4270	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	04037691838663	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K132166	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			connector size blood inlet 1/2 Inch
Total Volume	4200	Milliliter
Pore Size	68	Micrometer
Device Size Text, specify			minimum operating volume 200 milliliter
Device Size Text, specify			pore size cardiotomy filter 40 micrometer
Device Size Text, specify			connector size blood outlet 3/8 Inch