Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651299854
• Version / Model: 29985
• Catalog Number: 29985
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2023-07-31
• Public Version: 1
• Public Version Date: 2023-08-08
• Public Version Status: New
• Public Device Record Key: 749968c8-a48e-4c0e-a436-2c29a9dcbe14

Device Description

HAND-AID* Arterial Replacement Pad with Straps

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: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ILH	SPLINT, HAND, AND COMPONENTS	Physical Medicine	890.3475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
45128	Wrist immobilizer, single-use	A rigid support designed to temporarily render the wrist immovable (i.e., prevention of flexion, extension, and rotation) as therapy for non-displaced fractures, strains, sprains, and muscle injuries of the wrist and/or to prevent injury during a procedure (e.g., radial catheterization). The rigid support typically includes a wrap which may be held in place with a fastener such as Velcro; it is available in a variety of sizes. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651299858	GS1	CS	2	In Commercial Distribution
Primary	10680651299854	GS1
Unit of Use	90680651299850	GS1

Customer Contacts

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