Insufflation Tubing, Gen Use CPC

FDA UDI

Class II (US FDA UDI)

by Northgate Technologies Inc.

Identity

Trade Name: Insufflation Tubing, Gen Use CPC FDA UDI
Generic Name: Endoscopic insufflation tubing set, single-use FDA UDI
Device Name: Insufflation Tubing for use with Laparoscopic Insufflators FDA UDI
Model / Reference: 7-510-28 FDA UDI
Description: Insufflation Tubing for use with Laparoscopic Insufflators FDA UDI

Identifiers

Primary DI / UDI-DI: 00817183020325 FDA UDI
510(k) Number: K914403 FDA UDI
FDA Product Code: HIF FDA UDI
GMDN Term: Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 884.1730 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

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscopic insufflation tubing set, single-use

Insufflation Tubing, Gen Use CPC by Northgate Technologies Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K914403 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Northgate Technologies Inc.

Sources (1)

FDA UDI 0bd769c7-b6d3-4d49-a6ad-ceeee04aa447 34 fields · synced May 30, 2026