Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651947298
• Version / Model: 94729
• Catalog Number: 00315-08Z -No C
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-03-15
• Public Version: 5
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 4a9edc02-8332-4f03-ad7b-f5c3eefd3d1c
• Distribution End Date: 2019-11-19

Device Description

HALYARD* Thermal Pad - Split Torso Large

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: 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: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DWJ	System, thermal regulating	Cardiovascular	870.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36854	External circulating-fluid core temperature regulation system pad, reusable	An underlay, overlay, or wrap(s) through which temperature-regulated fluid is circulated, as part of an external circulating-fluid core temperature regulation system, intended to elevate and/or lower a patient’s core body temperature, typically in the operating room (OR), intensive care unit (ICU), or a recovery unit. The underlay/overlay is available in a variety of lengths, widths, and thicknesses to accommodate body size and application (e.g., adult/paediatric). It is intended to be used by a healthcare professional in a clinical setting. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10680651947298	GS1
Package	30680651947292	GS1		5	Not in Commercial Distribution	2019-11-19

Customer Contacts

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