FDA.report

Ventlab

Primary DI
10889483172377
Brand
Ventlab
Company
VENTLAB, LLC
Model
5107F-SE
Catalog number
5107F-SE
Device description
Adult 7ft ETCO2 Cannula Assembly with Fits-all & Reflective Connector
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

Related Records

Contact Domains

Product Codes

CodeName
CCKANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Product Code Classifications

CodeDeviceSpecialtyClass
CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-PhaseAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10889483172377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1088948317237710889483172377

GMDN Terms

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

TypeValueUnit
Length7Feet

Sterilization Methods

Method

Contacts

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

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