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Nellcor

FDA UDI

Class II (US FDA UDI)

by Covidien LP

Identity

Trade Name
Nellcor FDA UDI
Generic Name
Exhaled-gas oesophageal intubation detector FDA UDI
Device Name
Pediatric Colorimetric CO2 Detector FDA UDI
Model / Reference
PEDICAP 6 FDA UDI
Description
Pediatric Colorimetric CO2 Detector FDA UDI

Identifiers

Primary DI / UDI-DI
20884521112862 FDA UDI
510(k) Number
K203762 FDA UDI
K944400 FDA UDI
FDA Product Code
CCK FDA UDI
GMDN Term
Exhaled-gas oesophageal intubation detector 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Exhaled-gas oesophageal intubation detector

Nellcor by Covidien LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Exhaled-gas oesophageal intubation detector.

Cleared under the same submission

K203762 also covers:

K944400 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Covidien LP

Sources (1)

  • FDA UDI d58e31a9-5981-4d3f-a41e-55ed6314b5ce 37 fields · synced May 30, 2026