LoFlo

FDA UDI

Class II (US FDA UDI)

by Respironics Novametrix, LLC

Identity

Trade Name: LoFlo FDA UDI
Generic Name: Nasal oxygen cannula, carbon-dioxide-sampling FDA UDI
Device Name: LoFlo CO2 Sampling O2 Delivery Cannula w/Dehumidification Tubing INFANT/NEONATAL NASAL FDA UDI
Model / Reference: 1149476 FDA UDI
Description: LoFlo CO2 Sampling O2 Delivery Cannula w/Dehumidification Tubing INFANT/NEONATAL NASAL FDA UDI

Identifiers

Catalog Number: 1149476 FDA UDI
Primary DI / UDI-DI: 00884838104860 FDA UDI
FDA Product Code: CCK FDA UDI
GMDN Term: Nasal oxygen cannula, carbon-dioxide-sampling 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

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

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Nasal oxygen cannula, carbon-dioxide-sampling

LoFlo by Respironics Novametrix, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Respironics Novametrix, LLC

Sources (1)

FDA UDI e2f4d1b4-82ae-43b7-ab5d-7e18ee16b8f3 36 fields · synced Jun 8, 2026