FDA.report

HUDSON RCI

Primary DI
20197344009753
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD3230
Catalog number
HUD3230
Device description
HUMIDIFIER,EMPTY,STANDARD,500ML,4 PSI
Published
2024-09-24
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
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications

CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions

SubmissionSupplement
K230559000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K230559000Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260)Medline Industries, Inc.2023-10-26BTT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20197344009753PackageGS150In Commercial Distribution
10197344009756PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019734400975320197344009753
1019734400975610197344009756

GMDN Terms

TermDefinition
Non-heated respiratory humidifierA device designed to prevent the drying of airway passages associated with the inhalation of oxygen (O2) by adding water vapour to the dry gas as it is passed through, or more seldom, over water. It typically consists of a graduated container (reservoir) for the water, a top piece that functions as a detachable lid (typically a screw lid with a gastight seal), and a tube that protrudes into the water to divert the gas below the water level. This device, commonly known as a bubble humidifier, does not heat the water. It has connectors: 1) one (e.g., a winged nut) that connects to an oxygen therapy flowmeter; and 2) one to which the patient tubing is connected. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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