BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

HUDSON RCI

DI: 04026704398249 · Model: IPN044921 · TELEFLEX INCORPORATED

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Product Codes

1

GMDN Terms

1

Identifiers

3

Pkg Device Count

1

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Basic Information

Brand Name: HUDSON RCI
Primary DI: 04026704398249
Version / Model: IPN044921
Catalog Number: 5-24004
Company Name: TELEFLEX INCORPORATED
Labeler DUNS: 002348191
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-10-16
Public Version: 3
Public Version Date: 2018-07-06
Public Version Status: Update
Public Device Record Key: 6afbb6fe-1e01-44ee-bb97-507700dc340f

Device Description

ET TUBE, EXCHANGER, TTX, 6.0 - 8.5 MM

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
BTR	Tube, tracheal (w/wo connector)	Anesthesiology	868.5730	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42084	Endotracheal tube guide, single-use	A device used to provide guidance when it is necessary to exchange an endotracheal (ET) tube which has been intubated into a patient. The guide is inserted into the existing tube which is then retracted over the guide. The new ET tube is inserted over the guide to facilitate its correct passage, and the guide is removed once the new tube is satisfactorily in place. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24026704398243	GS1	Box	10	In Commercial Distribution
Primary	04026704398249	GS1
Package	44026704398247	GS1	Case	10	In Commercial Distribution

Customer Contacts

Phone: +1(919)544-8000
Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K862347	000

Device Sizes

Type	Value	Unit	Text
Length	810	Millimeter
Device Size Text, specify			Sheridan T.T.X. Tracheal Tube Exchanger

Storage Conditions

Type: Storage Environment Temperature
Temperature Range: 32 – 122 Degrees Fahrenheit