US Blood And Urine Kit

Basic Information

• Brand Name: US Blood And Urine Kit
• Primary DI: 00850054552037
• Version / Model: Exempt
• Company Name: Quest Diagnostics
• Labeler DUNS: 189222334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-01
• Public Version: 2
• Public Version Date: 2026-03-04
• Public Version Status: Update
• Public Device Record Key: 74324ab9-1656-4303-8b8f-2cebe6c3b1d8

Device Description

US Blood And Urine Kit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
58497	Blood collection set, invasive	A collection of devices intended to be used by a healthcare professional, in combination with evacuated blood collection tubes, for the routine collection of multiple blood specimens from a patient, via one venipuncture, for clinical analyses. It consists of a blood collection needle or venous butterfly/scalp vein needle and additional devices that may include tubing, male/female Luer-lock connectors, clamps, and a blood collection tube holder. Blood access is directly through the vein with the needle. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850054552034	GS1		10	In Commercial Distribution
Primary	00850054552037	GS1
Package	20850054552031	GS1		25	In Commercial Distribution
Package	30850054552038	GS1		50	In Commercial Distribution

Customer Contacts

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