CAPIOX® VENOUS RESERVOIR

Basic Information

• Brand Name: CAPIOX® VENOUS RESERVOIR
• Primary DI: 04987350706591
• Version / Model: CX*VRA0701T2
• Company Name: TERUMO CORPORATION
• Labeler DUNS: 690543319
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-09-15
• Public Version: 3
• Public Version Date: 2020-01-22
• Public Version Status: Update
• Public Device Record Key: 07b5e79b-df2d-4925-9140-9d7a04455382

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
DTM	Filter, Blood, Cardiopulmonary Bypass, Arterial Line	Cardiovascular	870.4260	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	34987350706592	GS1		4	In Commercial Distribution
Primary	04987350706591	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Fragile. This way up. Keep away from sunlight. Keep away from rain.
• Type: Handling Environment Temperature
• Temperature Range: 1 – 40 Degrees Celsius