DualGuard Endoscopy Mouthpiece Adult

FDA UDI

Class I (US FDA UDI)

by Flexicare Medical Limited

Identity

Trade Name: DualGuard Endoscopy Mouthpiece Adult FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: 10ft O2 Delivery/CO2 Monitoring Filter w/Microstream Type Luer FDA UDI
Model / Reference: 032-10-870U FDA UDI
Description: 10ft O2 Delivery/CO2 Monitoring Filter w/Microstream Type Luer FDA UDI

Identifiers

Primary DI / UDI-DI: 05055788781776 FDA UDI
FDA Product Code: MNK FDA UDI
CAT FDA UDI
CCK FDA UDI
GMDN Term: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 876.1500 FDA UDI
868.5340 FDA UDI
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

FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

DualGuard Endoscopy Mouthpiece Adult by Flexicare Medical Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Nasal oxygen cannula, carbon-dioxide-sampling.

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Microstream Advance — ORIDION MEDICAL 1987 LTD. · Class II
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Curaplex — TRI-ANIM HEALTH SERVICES, INC. · Class II
HUDSON RCI — TELEFLEX INCORPORATED · Class II

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: Flexicare Medical Limited

Sources (1)

FDA UDI 30912c13-70e9-4cac-8413-4721d6df3d7d 33 fields · synced May 30, 2026