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Nim®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
NIM® FDA UDI
Generic Name
Reinforced endotracheal tube, single-use FDA UDI
Device Name
ENDOTRACH TUBE 8229308 NIM EMG 8MM ROHS FDA UDI
Model / Reference
8229308 FDA UDI
Description
ENDOTRACH TUBE 8229308 NIM EMG 8MM ROHS FDA UDI

Identifiers

Primary DI / UDI-DI
00643169358737 FDA UDI
510(k) Number
K925640 FDA UDI
FDA Product Code
ETN FDA UDI
GMDN Term
Reinforced endotracheal tube, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.1820 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 11.3 Millimeter FDA UDI
Outer Diameter — 8.0 Millimeter FDA UDI

Nim® by Medtronic Xomed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K925640 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 4746c865-104f-4f79-a634-dd259159ee0e 37 fields · synced Jun 6, 2026