Capiox® Hardshell Reservoir

Basic Information

• Brand Name: Capiox® Hardshell Reservoir
• Primary DI: 00699753450165
• Version / Model: CX*SXRX
• Company Name: Terumo Cardiovascular Systems Corporation
• Labeler DUNS: 177655466
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-02
• Public Version: 5
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: b1575053-c761-40cc-9876-f6b078f66a59
• Distribution End Date: 2018-12-01

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: No
• 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
DTZ	Oxygenator, Cardiopulmonary Bypass	Cardiovascular	870.4350	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	50699753450160	GS1	4 Piece Case	4	Not in Commercial Distribution	2018-12-01
Primary	00699753450165	GS1

Premarket Submissions

Submission Number	Supplement Number
K130359	000