FDA.report

HUDSON RCI

Primary DI
14026704597304
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN040650
Catalog number
048-91
Device description
AQUATHERM HEATER 091
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
BZEHEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER

Product Code Classifications

CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
14026704597304Direct MarkingGS10
04026704597307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
1402670459730414026704597304
04026704597307040267045973074026704597307

GMDN Terms

TermDefinition
Benchtop nebulizer, heatedAn assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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