FDA.reportPublic FDA data

Pedi Co2 Easy

Primary DI
10889483222034
Brand
Pedi Co2 Easy
Company
SUNMED, LLC
Model
562135
Device description
Pedi CO2 Easy® Carbon Dioxide Detector
Published
2026-03-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20889483222031PackageGS110In Commercial Distribution
10889483222034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088948322203120889483222031
1088948322203410889483222034

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.

Regulatory Flags#

DUNS number
069009268
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10889483155912SunMed4-0050-10M4-0050-10M2023-07-18
10889483225448Septal-H™CP-5410CP-54102025-12-15
10889483225455Septal-H™CP-5500CP-55002025-12-15
10889483230244AirLife™TC-1022TC-10222025-12-15
10889483033289SunMed9-0210-019-0210-012024-03-12
10889483564578BALLARD™221036-5227036-52025-11-21
10889483040218SunMed5-0236-315-0236-312023-03-21
10889483221150AirLife™093709372025-12-18
10889483221181Vital Signs™8809-W8809-W2025-12-23
10889483221747AirLife™026202622025-12-19
10889483222027Co2 Easy5621342026-03-31
10889483222157Ambu900-000-601900-000-6012025-12-19
10889483222164Ambu900-000-602900-000-6022025-12-19
10889483222188Ambu900-000-604900-000-6042025-12-19
10889483222195Ambu900-000-605900-000-6052025-12-19
10889483222201Ambu900-000-606900-000-6062025-12-19
10889483222225Ambu900-000-609900-000-6092025-12-19
10889483222232Ambu900-000-611900-000-6112025-12-19
10889483222393AirLife™056205622025-12-18
10889483222485Vital Signs™51260A-568551260A-56852025-12-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479282190McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282213McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282237McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282251McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282275McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282299McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
10612479282312McKessonMCKESSON MEDICAL-SURGICAL INC.CCK2026-04-14
09555866301385DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2026-04-02
10197344162550MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
10197344162567MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-10-17
09555866300869DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
10884389815311MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
10884389815069MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
10197344111107MEDLINEMEDLINE INDUSTRIES, INC.CCK2024-09-09
10841522126413TrulinkSPACELABS HEALTHCARE (WASHINGTON), INCCCK2024-07-16
10843997017685NomolineMASIMO CORPORATIONCCK2024-03-19
10620974003684Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2024-01-26
10620974003097Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003103Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003127Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003134Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003158Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003165Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003172Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003189Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003202Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003219Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003226Oxy2Mask O2/EtCO2Southmedic IncorporatedCCK2023-12-01
10620974003608Oxy2ProSouthmedic IncorporatedCCK2023-12-01
10620974003615Oxy2ProSouthmedic IncorporatedCCK2023-12-01