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Tracheal Tube

FDA UDI

Class II (US FDA UDI)

by North American Rescue, Llc.

Identity

Trade Name
Tracheal Tube FDA UDI
Generic Name
Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI
Device Name
TRACHEAL TUBE - CUFFED 6.0mm ID FDA UDI
Model / Reference
ZZ-0269 FDA UDI
Description
TRACHEAL TUBE - CUFFED 6.0mm ID FDA UDI

Identifiers

Catalog Number
ZZ-0269 FDA UDI
Primary DI / UDI-DI
00842209105021 FDA UDI
510(k) Number
K042684 FDA UDI
FDA Product Code
BTO FDA UDI
GMDN Term
Tracheostomy tube, non-reinforced, non-customized, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
868.5800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 6.0 Millimeter FDA UDI

Tracheal Tube by North American Rescue, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K042684 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
North American Rescue, Llc.

Sources (1)

  • FDA UDI 509cae7d-350a-47fe-bcba-b2a59a006e61 37 fields · synced Jun 8, 2026