TandemHeart

Basic Information

• Brand Name: TandemHeart
• Primary DI: 00814112020029
• Version / Model: 5100-0011
• Company Name: CARDIACASSIST, INC.
• Labeler DUNS: 948683941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2015-10-10
• Public Version: 3
• Public Version Date: 2018-10-03
• Public Version Status: Update
• Public Device Record Key: ab75e10b-64c0-4813-8003-947f2f0903b6

Device Description

Infusion tubing (5 pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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
DWF	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	Cardiovascular	870.4210	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46846	Mechanical infusion pump administration set	A collection of sterile devices intended to be used with a mechanical infusion pump (non-electric) to enable the intermittent or continuous infusion of medication, typically for antibiotic therapy, chemotherapy, or pain management [including patient-controlled analgesia (PCA)] by intravenous (IV), subcutaneous, intramuscular, or epidural routes. It typically consists of a reservoir (e.g., a plastic pouch), plastic tubing, a check valve, a line clamp, and Luer connectors. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814112020029	GS1
Unit of Use	00814112020005	GS1

Customer Contacts

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