FDA.reportPublic FDA data

Ventlab

Primary DI
10889483172735
Brand
Ventlab
Company
VENTLAB, LLC
Model
4214F
Catalog number
4214F
Device description
PEDI ETCO2 14ft CANNULA ASSEMBLY w/ FITS ALL
Published
2023-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10889483172735PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088948317273510889483172735

GMDN Terms#

Term, Definition table
TermDefinition
Exhaled-gas oesophageal intubation detector, adultA device designed to verify proper endotracheal (ET) tube placement by detecting/assessing escaping levels of exhaled carbon dioxide (CO2) during airway management disclosing potential incorrect intubation. It is used during adult intubation and is attached directly between the ET tube and the breathing device. It typically functions through colorimetric CO2 detection using an indicator paper that changes colour. A colour chart (e.g., attached to the device) permits interpretation into approximate CO2 concentration. It is used in healthcare facilities or in the field to evaluate oesophageal intubation, which if performed incorrectly, prevents patient ventilation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Feet

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)433-2797info@sun-med.com

Regulatory Flags#

DUNS number
038305402
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30889483644540AirFlowAF5142MB-PWAF5142MB-PW2025-11-25
30889483631526AirFlow™AF2102MCP-3AF2102MCP-32025-02-03
30889483631533AirFlow™AF5102MC-PAF5102MC-P2025-01-31
10889483555675VentlabAF2142MB-M5EAF2142MB-M5E2024-03-12
10889483555682VentlabAF5000MB-EAF5000MB-E2024-03-12
10889483555699VentlabAF5040MB-EAF5040MB-E2024-03-12
10889483555705VentlabAF5040MBP-EAF5040MBP-E2024-03-12
10889483555712VentlabAF5140MB-EAF5140MB-E2024-03-12
10889483555729VentlabAF5140MBP-EAF5140MBP-E2024-03-12
10889483555736VentlabAF5142MBP-EAF5142MBP-E2024-03-12
10889483555743VentlabAF2000MB-EAF2000MB-E2024-03-12
10889483555750VentlabAF2040MB-EAF2040MB-E2024-03-12
10889483555767VentlabAF2040MBP-EAF2040MBP-E2024-03-12
10889483555774VentlabAF2140MB-EAF2140MB-E2024-03-12
10889483555781VentlabAF2140MBP-EAF2140MBP-E2024-03-12
10889483555798VentlabAF2142MBP-EAF2142MBP-E2024-03-12
10889483555804VentlabAF2144MB-EAF2144MB-E2024-03-12
10889483555811VentlabAF5140MB-ZAF5140MB-Z2024-03-12
10889483555828VentlabAF5140MBP-ZAF5140MBP-Z2024-03-12
10889483555835VentlabAF5040MBP-ZAF5040MBP-Z2024-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20889483226435Bell Medical CannulaSALTER LABSCCK2026-03-13
04048675448884Sample Line Set (10pcs)Drägerwerk AG & Co. KGaACCK2026-02-16
20889483230555AirLife™SUNMED, LLCCCK2025-12-31
20889483221157AirLife™SUNMED, LLCCCK2025-12-18
20889483222390AirLife™SUNMED, LLCCCK2025-12-18
20889483230364AirLife™SUNMED, LLCCCK2025-12-18
10885403520761BD Alaris™ ETCO2 Module, Model 8300CAREFUSION 303, INC.CCK2025-09-10
15055140702804MediplusMEDIPLUS LTDCCK2025-08-29
00810094579562Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
00810094579579Curaplex®BOUND TREE MEDICAL, LLCCCK2025-08-06
30889483236325Iradimed Adult Capnography CannulaSALTER LABSCCK2025-08-04
30889483236332Iradimed Infant Capnography CannulaSALTER LABSCCK2025-08-04
30889483236349Iradimed Pediatric Capnography CannulaSALTER LABSCCK2025-08-04
30889483236356IradimedSALTER LABSCCK2025-08-04
30889483236363IradimedSALTER LABSCCK2025-08-04
30889483236370IradimedSALTER LABSCCK2025-08-04
30889483236387IradimedSALTER LABSCCK2025-08-04
30889483236318Iradimed Sample Line ExtensionSALTER LABSCCK2025-08-04
09555866300876DISPO-MEDDISPO-MED (MALAYSIA) SDN. BHD.CCK2025-08-01
20885632455442Halyard Gas Sampling LineAIRLIFECCK2025-07-25
10885632455452Halyard Gas Sampling LineAIRLIFECCK2025-07-25
20888277420592MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-06-13
00840117342361Resp-O2 EtCO2 Nasal Sampling Cannula, 10' (3.0m) O2 and CO2 TubingDynarex CorporationCCK2025-06-09
00840117342385Resp-O2 EtCO2 Nasal Sampling Cannula, 14" (4.2 m ) O2 and CO2 Tubing Dynarex CorporationCCK2025-06-09
00840117342408Resp-O2 EtCO2 Nasal Sampling Cannula, 14' (4.2 m) O2 and CO2Dynarex CorporationCCK2025-06-09
20884389815318MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-25
20884389815066MEDLINEMEDLINE INDUSTRIES, INC.CCK2025-04-24
20889483600501Vital Signs™AirLife Finland OyCCK2025-04-02
00843997016544NomolineMASIMO CORPORATIONCCK2025-04-01
20889483600518Vital Signs™AirLife Finland OyCCK2025-03-31