Steris

FDA UDI

Class I (US FDA UDI)

by Canadian Hospital Specialties Limited

Identity

Trade Name: Steris FDA UDI
Generic Name: Endoscopic insufflation tubing set, single-use FDA UDI
Device Name: INSUFFLATION TUBING,QUICK CONNECTOR FDA UDI
Model / Reference: FL2107 FDA UDI
Description: INSUFFLATION TUBING,QUICK CONNECTOR FDA UDI

Identifiers

Catalog Number: FL2107 FDA UDI
Primary DI / UDI-DI: 00628725007366 FDA UDI
FDA Product Code: NKC FDA UDI
GMDN Term: Endoscopic insufflation tubing set, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 884.1730 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Endoscopic insufflation tubing set, single-use

Steris by Canadian Hospital Specialties Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Endoscopic insufflation tubing set, single-use.

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ENDO SMARTCAP — MEDIVATORS INC. · Class II
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MediChoice — OWENS & MINOR DISTRIBUTION, INC. · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Canadian Hospital Specialties Limited

Sources (1)

FDA UDI c59856a2-fea4-4d1a-a6d7-a3a9c21b247b 34 fields · synced Jun 8, 2026