Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 10192253053005
• Version / Model: 61000
• Catalog Number: 61000-
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-08
• Public Version: 1
• Public Version Date: 2024-02-16
• Public Version Status: New
• Public Device Record Key: 9d0a76c3-8bc1-4daf-affc-d868204ccca7

Device Description

Solution Bowl

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42891	General-purpose bowl, single-use	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This disposable device will typically be incinerated along with its contents if used for waste. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50192253053003	GS1	CASE	75	In Commercial Distribution
Primary	10192253053005	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	16	Fluid Ounce