HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00849027003805
• Version / Model: HCS1320Y
• Company Name: DYAD MEDICAL SOURCING, LLC
• Labeler DUNS: 078572603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 1
• Public Version Date: 2020-09-08
• Public Version Status: New
• Public Device Record Key: c073b3e4-01c4-41f4-85f4-240938b85711

Device Description

Patient ID Band, Yellow "Fall Risk” Alert

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
FZZ	Marker, Skin	General, Plastic Surgery	878.4660	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32048	Patient identification band	A single-piece circular band designed to be worn around the wrist (i.e., bracelet, wristband), or sometimes ankle in babies, to provide identification and basic information about a patient. It is typically a slender, thin, and soft plastic band, with a self-locking device, that usually includes printed information with the name, date of birth, patient registration number, and other data that permit clear and easy identification of a patient in the healthcare facility. Some devices also include bar-code information intended for reading with a computerized reader/scanner.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849027003802	GS1	case	10	In Commercial Distribution
Primary	00849027003805	GS1
Unit of Use	20849027003809	GS1