FDA.reportPublic FDA data

Medex

Primary DI
10351688517050
Brand
Medex
Company
ICU MEDICAL, INC.
Model
114120
Published
2016-10-11
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
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K993282000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993282000IPI HUMIDIFIER CHAMBERI.P.I. Medical Products2000-09-18BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30351688517054PackageGS140In Commercial Distribution
10351688517050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3035168851705430351688517054
1035168851705010351688517050

GMDN Terms#

Term, Definition table
TermDefinition
Heated respiratory humidifierA mains electricity (AC-powered) device designed to heat and humidify air/oxygen inspired by a patient to help maintain the mucous membranes of the respiratory tract typically during periods of prolonged respiratory support/therapy (e.g., mechanical ventilation, BPAP/CPAP therapy). The heated/humidified gases are delivered to the patient's airway and lungs via the nose/mouth or a tracheostoma in association with a parent respiratory device (e.g., ventilator, BPAP/CPAP unit). The humidifier typically includes a heating element and provisions for attaching a humidification chamber and tubing set.

Regulatory Flags#

DUNS number
118380146
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10887709207735BivonaHT26JS80NSC205N2026-10-28
10887709207742BivonaFT26JN60NSA203N2026-10-28
10887709207759BivonaST26JN55NSA204N2026-10-28
10887709207766BivonaFT26JN35NGE206N2026-10-28
10887709207773BivonaFP26JN35NSF202N2026-10-28
10887709207780BivonaFT26JN50NGF207N2026-10-28
10887709207797BivonaFT26JN60NSC214N2026-10-28
10887709207803BivonaFT26JN55NGF213N2026-10-28
10887709207810BivonaFT26JN40NSE215N2026-10-28
10887709207827BivonaFT26JN35NGE212N2026-10-28
10887709207834BivonaFT26JN45NGF211N2026-10-28
10887709207841BivonaFT26JN50NGF210N2026-10-28
10887709207858BivonaFT26JN35NGE209N2026-10-28
10887709207865BivonaFT26JN35NGE217N2026-10-28
10887709207872BivonaFT26JN30NGE216N2026-10-28
10887709207285BivonaFU26JN60NGA169N2026-10-27
10887709207292BivonaSA26JN75NSC152N2026-10-27
10887709207308BivonaSU26JN40NSB163S2026-10-27
10887709207315BivonaFU26JN45NSF173N2026-10-27
10887709207322BivonaXT26JS80NSC172N2026-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850018561716NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561723NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561730NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561785NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561792NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561808NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561815NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561822NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561839NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561846NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561853NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
00850018561860NeoPod T, Neonatal Transport Humidification SystemINTERNATIONAL BIOMEDICAL, LTD.BTT2026-10-13
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10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
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