URINE SAMPLE KIT  1 TUBE & NAPKINS SI

Basic Information

• Brand Name: URINE SAMPLE KIT 1 TUBE & NAPKINS SI
• Primary DI: 15713311000080
• Version / Model: 551314
• Company Name: Nunc A/S
• Labeler DUNS: 305971764
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-08-17
• Public Version: 1
• Public Version Date: 2018-09-17
• Public Version Status: New
• Public Device Record Key: bb47d0e6-b6b2-48c5-9b2f-9e7a8b1e06e4

Device Description

URINE SAMPLE KIT  1 TUBE & NAPKINS SI

Device Characteristics

• Single Use: No
• 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: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

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

GMDN Terms

Code	Name	Definition	Implantable	Status
47776	General specimen container IVD, no additive, sterile	A sterile covered plastic receptacle containing no additives intended to be used for the collection, and preservation and/or transport, of any type of diagnostic specimen (e.g., urine, faeces, sputum, mucous, tissue) for analysis and/or other investigation. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05713311000083	GS1	Case	60	In Commercial Distribution
Primary	15713311000080	GS1