LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal

Basic Information

• Brand Name: LabChoice Specimen Container, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal
• Primary DI: 00616784425313
• Version / Model: 4253
• Company Name: Dynarex Corporation
• Labeler DUNS: 008124539
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-21
• Public Version: 3
• Public Version Date: 2025-05-20
• Public Version Status: Update
• Public Device Record Key: 78c54cc7-6d9a-4d4c-9ad3-f1218d2032e1

Device Description

Sterile-EO

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: 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: 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
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
Package	00616784425337	GS1	Case	100	In Commercial Distribution
Primary	00616784425313	GS1