RTube

Basic Information

• Brand Name: RTube
• Primary DI: 00860009311602
• Version / Model: 2501
• Catalog Number: 2501
• Company Name: Respiratory Research Inc
• Labeler DUNS: 157929535
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-21
• Public Version: 1
• Public Version Date: 2023-11-29
• Public Version Status: New
• Public Device Record Key: 763f535d-987f-4aeb-8237-6df2dae2d558

Device Description

RTube Single-use disposable exhaled breath condensate collector.

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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KGK	Gas, Collecting Vessel	Anesthesiology	868.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33513	Exhaled-gas sample collector, non-electronic	A container intended to collect a sample of a patient's exhaled gas for subsequent analysis. The container may be flexible or rigid and may have a soft disposable liner in which the sample is collected. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860009311602	GS1