FDA.report

HUDSON RCI

Primary DI
20193489149408
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD50025
Catalog number
HUD50025
Device description
CHAMBER, HUMIDIFICATION, DISPOSABLE
Published
2024-03-28
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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489149408PackageGS110In Commercial Distribution
10193489149401PrimaryGS10
80193489149400Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348914940820193489149408
1019348914940110193489149401
8019348914940080193489149400

GMDN Terms

TermDefinition
Inspiratory line humidification chamber, single-useA device intended to be fitted to a heated inspiratory line humidifier (e.g., positive-airway-pressure sleep apnoea treatment unit humidifier, heated inspiratory line humidifier) to contain water for the purpose of humidifying respiratory gases. It is a plastic chamber intended to allow the water to be heated by the attached humidifier and the subsequent vapour to be delivered to the patient through a connected breathing circuit. It may be used in a healthcare setting or in the home. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight. Keep Dry.

Sterilization Methods

Method

Contacts

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

Regulatory Flags

DUNS number
025460908
Device count
2
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
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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