Medline

Basic Information

• Brand Name: Medline
• Primary DI: 10080196032006
• Version / Model: DYND30215
• Catalog Number: DYND30215
• Company Name: MEDLINE INDUSTRIES, INC.
• Labeler DUNS: 025460908
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-08-21
• Public Version: 1
• Public Version Date: 2021-08-30
• Public Version Status: New
• Public Device Record Key: ac0c026d-91fb-4f3a-acac-3ec0f3555af2

Device Description

KIT,MIDSTREAM,FUNNEL,BZK,4OZ CUP

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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: 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
OIE	Urine collection kit (excludes HIV testing)	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
Package	40080196032007	GS1	CASE	20	In Commercial Distribution
Primary	10080196032006	GS1

Customer Contacts

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