DeRoyal

FDA UDI

Class II (US FDA UDI)

by Deroyal Industries, Inc.

Identity

Trade Name: DeRoyal FDA UDI
Generic Name: Anaesthesia breathing circuit, single-use FDA UDI
Device Name: Gas Sample Line FDA UDI
Model / Reference: 83-000107 FDA UDI
Description: Gas Sample Line FDA UDI

Identifiers

Primary DI / UDI-DI: 00749756138383 FDA UDI
510(k) Number: K946044 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Anaesthesia breathing circuit, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 868.1400 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Anaesthesia breathing circuit, single-use

DeRoyal by Deroyal Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Anaesthesia breathing circuit, single-use.

Vital Signs™ — Airlife, Inc. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class I
Vital Signs™ — Airlife, Inc. · Class I
UNIVERSAL FLEX2®BREATHING CIRCUIT & PACK KIT — KING SYSTEMS CORPORATION. · Class I
Vital Signs™ — Airlife, Inc. · Class I
Portex — ICU MEDICAL, INC. · Class I
UNIVERSAL FLEX2® — KING SYSTEMS CORPORATION. · Class I
PEDIATRIC ULTRA FLEX® — KING SYSTEMS CORPORATION. · Class I

Cleared under the same submission

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Deroyal Industries, Inc.

Sources (1)

FDA UDI 01405032-3fb3-4490-a318-4f0a4ada20c2 35 fields · synced Jun 8, 2026