Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 20680651536055
• Version / Model: 53605
• Catalog Number: 53605
• Company Name: O&M HALYARD, INC.
• Labeler DUNS: 081057389
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 15
• Record Status: Published
• Publish Date: 2020-11-18
• Public Version: 1
• Public Version Date: 2020-11-26
• Public Version Status: New
• Public Device Record Key: 249e48ab-c8d5-4ea2-9979-e0a7ff979fde

Device Description

O.R. Tourniquet Cover, 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: 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: 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
IPM	COVER, LIMB	Physical Medicine	890.3025	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47949	Tourniquet cuff bandage, non-latex	A sterile strip or roll of non-latex containing material that is applied around an extremity (arm or leg) before the fitting of a tourniquet cuff on top of it. This device is used to protect the patient's skin from wrinkling, pinching or shearing and to protect the tourniquet cuff from becoming soiled with blood and other fluids from the operative site. It would typically be folded back over the exposed edges of the cuff to provide maximum protection. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651536052	GS1	CS	2	In Commercial Distribution
Primary	20680651536055	GS1
Unit of Use	90680651536054	GS1

Customer Contacts

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