Halyard

Basic Information

• Brand Name: Halyard
• Primary DI: 10680651468359
• Version / Model: 46835
• Catalog Number: N282139
• Company Name: Avanos Medical, Inc.
• Labeler DUNS: 079375431
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-07
• Public Version: 6
• Public Version Date: 2024-02-28
• Public Version Status: Update
• Public Device Record Key: fea10d9c-f442-4117-81ac-f7a446e023bf
• Distribution End Date: 2024-02-28

Device Description

Single-Shot Epidural Trays 10ea/bx

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CAZ	Anesthesia conduction kit	Anesthesiology	868.5140	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34852	Massage table/couch, non-powered, portable	A manually-adjusted, portable table designed for various kinds of complementary therapy (e.g., massage, acupuncture, aromatherapy, reflexology, kinesiology). It consists of a foldable framework (table top and legs) with a flat tabletop surface which may have a head section that can be manually adjusted. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may incorporate a face hole (the patients face fits into this when lying prone), a headrest, and an armrest(s). This device is typically known as a massage/therapy table, couch or bed.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30680651468353	GS1	CS	10	Not in Commercial Distribution	2024-02-28
Primary	10680651468359	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K941153	000