HCS

Basic Information

• Brand Name: HCS
• Primary DI: 00849027005168
• Version / Model: HCS0008D
• Company Name: DYAD MEDICAL SOURCING, LLC
• Labeler DUNS: 078572603
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-07-21
• Public Version: 1
• Public Version Date: 2020-07-29
• Public Version Status: New
• Public Device Record Key: 11747549-644f-4f79-b91b-163699415493

Device Description

PICC Line Advanced with Statlock Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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: 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
OWL	Peripheral Catheter Insertion Kit	General Hospital	880.5200	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64573	Peripheral intravenous catheterization kit	A collection of devices intended for the introduction of an included peripheral vein cannula, often referred to as a catheter, to enable short-term (= 30 days) intravenous (IV) access for administration of fluids/medication and blood sampling. In addition to the cannula, it includes non-dedicated devices intended to support the procedure [e.g., tourniquet, swabs, dressings, disinfectants (e.g., alcohol), tape, gloves]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10849027005165	GS1	case	30	In Commercial Distribution
Primary	00849027005168	GS1