Tracheal Tube ZZ-0269

GUDID 20842209105025

TRACHEAL TUBE - CUFFED 6.0mm ID

NORTH AMERICAN RESCUE, LLC

Basic tracheostomy tube, single-use
Primary Device ID20842209105025
NIH Device Record Key509cae7d-350a-47fe-bcba-b2a59a006e61
Commercial Distribution StatusIn Commercial Distribution
Brand NameTracheal Tube
Version Model NumberZZ-0269
Catalog NumberZZ-0269
Company DUNS832426782
Company NameNORTH AMERICAN RESCUE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter
Lumen/Inner Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100842209105021 [Primary]
GS110842209105028 [Package]
Contains: 00842209105021
Package: box [10 Units]
In Commercial Distribution
GS120842209105025 [Package]
Contains: 10842209105028
Package: case [10 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

BTOTube, Tracheostomy (W/Wo Connector)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2018-07-11
Device Publish Date2017-10-06

Devices Manufactured by NORTH AMERICAN RESCUE, LLC

00842209133697 - NAR2024-12-26
00842209133703 - NAR2024-12-26
00842209133710 - NAR2024-12-26
00842209133727 - NAR2024-12-26
00842209133734 - NAR2024-12-26
00842209133741 - NAR2024-12-26
00842209133758 - NAR2024-12-26
00842209133765 - NAR2024-12-26

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