Intuitive Depth Exchange™ Catheter (IDE)

FDA UDI

Class I (US FDA UDI)

by Through The Cords, Llc

Identity

Trade Name: Intuitive Depth Exchange™ Catheter (IDE) FDA UDI
Generic Name: Endotracheal tube guide, single-use FDA UDI
Device Name: Exchange Catheter with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes. FDA UDI
Model / Reference: 000294 FDA UDI
Description: Exchange Catheter with intuitive colored depth system, 70 CM, 15 Fr, not made with natural rubber latex, single use, sterile, fits 6.0 and larger ID tubes. FDA UDI

Identifiers

Primary DI / UDI-DI: 00860581002660 FDA UDI
FDA Product Code: BSR FDA UDI
GMDN Term: Endotracheal tube guide, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5790 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endotracheal tube guide, single-use

Intuitive Depth Exchange™ Catheter (IDE) by Through The Cords, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endotracheal tube guide, single-use.

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JEM 400 Endotracheal Tube Changer — INSTRUMENTATION INDUSTRIES, INCORPORATED · Class II
Aintree — COOK INCORPORATED · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II
Arndt — COOK INCORPORATED · Class I

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

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Manufacturer

Manufacturer: Through The Cords, Llc

Sources (1)

FDA UDI acbf4154-789d-455f-9cee-1fd89f2ce20b 33 fields · synced Jun 6, 2026