Specimen Container

Basic Information

• Brand Name: Specimen Container
• Primary DI: 00616784425634
• Version / Model: 4256
• Company Name: DYNAREX CORPORATION
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 500
• Record Status: Published
• Publish Date: 2021-09-01
• Public Version: 1
• Public Version Date: 2021-09-09
• Public Version Status: New
• Public Device Record Key: b9b393fc-8673-4963-add0-f13a4baf3453

Device Description

Specimen Containers, 4oz., Non-Sterile, Bulk Packed

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: Yes
• MRI Safety: MR Safe
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• 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
NNI	Container, Specimen, Non-Sterile	Pathology	864.3250	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57919	24-hour urine specimen container IVD, no additive	A capped plastic receptacle, typically 2 to 4 litres, with no additives and intended to be used for the collection, and preservation and/or transport, of urine collected over a 24-hour period for analysis and/or other investigation. 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	00616784425627	GS1
Primary	00616784425634	GS1