Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L

Basic Information

• Brand Name: Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L
• Primary DI: 00899054002821
• Version / Model: HAF-2SHS
• Company Name: KDL MEDICAL, INC.
• Labeler DUNS: 791048924
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2025-02-10
• Public Version: 1
• Public Version Date: 2025-02-18
• Public Version Status: New
• Public Device Record Key: 9db6fc44-ecb4-4968-860b-482932285404

Device Description

Heart Assist, Single Use, 2 Finger Short, Malleable 36mm W X 54mm L

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: 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: 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
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
62379	Surgical instrument assist arm system, manually-adjusted	A manually-powered/-adjusted device assembly intended to be used to hold, maintain in a desired position, and enable positional adjustment of surgical and/or endoscopic instruments during an endoscopic examination/surgical procedure (i.e., during use). It typically consists of rigid or semi-rigid arms with joints, instrument holding and locking mechanisms, and a clamping mechanism for fixation to a stable object (e.g., the operating table) or is mounted on a mobile (on wheels) base.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10899054002828	GS1
Primary	00899054002821	GS1

Customer Contacts

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