FDA.reportPublic FDA data

Nellcor

Primary DI
20884521083919
Brand
Nellcor
Company
Covidien LP
Model
PEDICAP
Device description
Pediatric Colorimetric CO2 Detector
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203762000
K944400000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203762000Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 DetectorCovidien2021-09-17CCK
K944400000PEDI-CAPNellcor, Inc.1994-09-27CCK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521083912PackageGS16In Commercial Distribution
30884521083916PackageGS14In Commercial Distribution
20884521083919PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452108391210884521083912
3088452108391630884521083916
2088452108391920884521083919

GMDN Terms#

Term, Definition table
TermDefinition
Exhaled-gas oesophageal intubation detectorA device designed to verify proper endotracheal (ET) tube placement by detecting/assessing exhaled carbon dioxide (CO2) during airway management to confirm correct intubation for appropriate ventilation; it may additionally be intended to confirm placement/ventilation when using a laryngeal mask airway and/or face mask. It is intended to be connected to the intubation device and/or ventilator breathing circuit (e.g., the T-piece connector or hose). It typically functions through colorimetric CO2 detection using a chemical reaction based and/or paper indicator that changes colour based on the approximate CO2 concentration. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature0 Degrees Fahrenheit75 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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10884521191013Endo GIAEGIATRS60AMT2015-09-01
10884521543522Tri-Staple 2.0SIGC60VT2017-05-26
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Primary DI, Brand, Company table
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10884521858107NellcorCovidien LPCCK2026-05-29
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