Kendall

Basic Information

• Brand Name: Kendall
• Primary DI: 50192253051689
• Version / Model: 8889207034
• Catalog Number: 8889207034
• Company Name: Cardinal Health 200, LLC
• Labeler DUNS: 961027315
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2024-12-02
• Public Version: 1
• Public Version Date: 2024-12-10
• Public Version Status: New
• Public Device Record Key: 12c0342d-c52c-4477-b2d4-b250497a311c

Device Description

Specimen Container

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: No
• 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
FMH	CONTAINER, SPECIMEN, STERILE	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
12542	Midstream urine specimen container IVD	A covered plastic receptacle with no additives intended to be used for the collection, and preservation and/or transport, of a midstream urine specimen for analysis and/or other investigation. The midstream is collected after an initial pre-measured volume of first-voided urine is diverted to a separate reservoir for discarding. Additional items may be included (e.g., towelettes). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10192253051681	GS1
Primary	50192253051689	GS1

Device Sizes

Type	Value	Unit	Text
Total Volume	4	Fluid Ounce