SUGAR, D-XYLOSE, 25 GM, PACKET

Basic Information

• Brand Name: SUGAR, D-XYLOSE, 25 GM, PACKET
• Primary DI: 00850010197197
• Version / Model: QT02700-25-SS
• Catalog Number: QT02700-25-S
• Company Name: QUINTRON INSTRUMENT COMPANY, INC.
• Labeler DUNS: 874498744
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-03-15
• Public Version: 1
• Public Version Date: 2023-03-23
• Public Version Status: New
• Public Device Record Key: 73282674-c665-4888-bd1e-aa9256992d21

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: 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: 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
61614	Breath specimen container IVD	A container (e.g., bag, tube) intended to contain a specimen of air exhaled from a patient for subsequent in vitro determination of chemical and/or biological markers (e.g., volatile organic compounds) in the specimen to aid metabolic profiling or the diagnosis of disorders [e.g., lipid peroxidation levels, gastrointestinal H. pylori infection, coronavirus disease (COVID-19) infection]. It may include a port for blowing into the container, an access device (e.g., tubing) to facilitate specimen collection, and/or an adaptor for connection to an analyser. 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	00850010197791	GS1
Primary	00850010197197	GS1