RTube

FDA UDI

Class I (US FDA UDI)

by Respiratory Research, Inc.

Identity

Trade Name: RTube FDA UDI
Generic Name: Exhaled-gas sample collector, non-electronic FDA UDI
Device Name: RTube Single-use disposable exhaled breath condensate collector. FDA UDI
Model / Reference: 2501 FDA UDI
Description: RTube Single-use disposable exhaled breath condensate collector. FDA UDI

Identifiers

Catalog Number: 2501 FDA UDI
Primary DI / UDI-DI: 00860009311602 FDA UDI
FDA Product Code: KGK FDA UDI
GMDN Term: Exhaled-gas sample collector, non-electronic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.1575 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Exhaled-gas sample collector, non-electronic

RTube by Respiratory Research, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exhaled-gas sample collector, non-electronic.

KIT, SAMPLE, AGENTS, 3160 — Philips DS North America LLC · Class II
GAS COLLECTING VESSEL — Hangzhou A-Tek Medical & Textiles Co., Ltd. · Class I
KIT, SAMPLE, AGENTS, 3160 — Philips DS North America LLC · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Respiratory Research, Inc.

Sources (1)

FDA UDI 763f535d-987f-4aeb-8237-6df2dae2d558 34 fields · synced May 30, 2026