HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00849027004642
• Version / Model: HCS9201-3000
• Company Name: DYAD MEDICAL SOURCING, LLC
• Labeler DUNS: 078572603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-29
• Public Version: 2
• Public Version Date: 2020-11-19
• Public Version Status: Update
• Public Device Record Key: 19b741b7-0654-42bf-894e-bd1787b067ad

Device Description

Pressure Infuser Cuff, 3000mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KZD	Infusor, Pressure, For I.V. Bags	General Hospital	880.5420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13100	Intravenous pressure infusor, manual, reusable	A manually-operated device designed to increase/control the rate of an intravenous (IV) solution given to a patient by manually applying pressure directly to the infusion bag. It is typically a flexible inflatable bag/cuff with a pocket to hold the infusion bag; it may include a squeeze bulb, mechanical screw, or spring mechanism to create the pressure. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849027004649	GS1	case	25	In Commercial Distribution
Primary	00849027004642	GS1