Avaline Medical NJ LLC

Basic Information

• Brand Name: Avaline Medical NJ LLC
• Primary DI: 00810077211847
• Version / Model: nsscX3
• Catalog Number: nsscX3
• Company Name: Avaline Medical NJ Limited Liability Company
• Labeler DUNS: 079767953
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 75
• Record Status: Published
• Publish Date: 2021-10-15
• Public Version: 2
• Public Version Date: 2023-06-20
• Public Version Status: Update
• Public Device Record Key: b116683b-0528-4f90-bfb2-ff99f6ab934b

Device Description

75 Vakly 4oz Specimen Cups with Screw On Lids - non Sterile

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: Yes
• 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
58177	Urine specimen collection kit IVD	A collection of noninvasive devices intended to be used for the collection, preservation, and transport of a urine specimen for culture, analysis, and/or other investigation. It typically consists of a primary urine collection receptacle (e.g., cup, conical tube, vessel), a urine preservation/transport tube [typically evacuated, with or without additives], and a transfer device for facilitating the aseptic transfer of a urine sample between receptacles; supportive devices for urine collection (e.g., wet wipes, absorbent pads, Foley catheter connector) and/or analysis [e.g., microscope slides, tube rack] may also be included in the kit. 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	00850025452618	GS1
Primary	00810077211847	GS1

Customer Contacts

• Phone: [phone] ext. 204
• Email: [email protected]