FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704660787
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049841
Catalog number
048-91
Device description
AQUATHERM HEATER 091
Published
2019-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BZEHeater, Breathing System W/Wo Controller (Not Humidifier Or NebulizerAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704660784Direct MarkingGS10
04026704597307PreviousGS10
14026704660787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670466078424026704660784
04026704597307040267045973074026704597307
1402670466078714026704660787

GMDN Terms#

Term, Definition table
TermDefinition
Nebulizing system, heatedAn assembly of devices designed to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) intended to be inhaled by a patient, typically used in the management of respiratory disorders [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of 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 table
Method

Contacts#

Phone, Email table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0503026704595222MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH MONITOR LINE Intersurgical IncorporatedBZE2025-04-16
0503026704588422MM SMOOTHBORE EXHALATION VALVE HEATED WIRE BREATHING SYSTEM WITH LIMB.1.6MIntersurgical IncorporatedBZE2025-04-16
30889483572126AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573383AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483573802AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
30889483605480AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616932AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
10889483616956AirLife™Sunmed Group Holdings, LLCBZE2025-03-27
0503026703366922MM FLEXTUBE DUAL HEATED WIRE BREATHING SYSTEM WITH EXTRA LIMBS.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709791322MM FLEXTUBE DUAL H/W B/S WITH AUTO-FILL CHAMBER AND EXTRA LIMBS. >1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703368322MM SMOOTHBORE SINGLE H/W BREATHING SYSTEM WITH WATER TRAP AND LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026709637422MM SMOOTHBORE SINGLE H/W B/S WITH WATER TRAP,AUTO-FILL CHAMBER,EXTRA LIMB>1.6MIntersurgical IncorporatedBZE2025-03-14
0503026703367622MM SMOOTHBORE DUAL H/W BREATHING SYSTEM WITH EXTRA LIMB. > 1.6MIntersurgical IncorporatedBZE2025-03-14
0503026716192822MM FLEXTUBE SINGLE H/W LIMB WITH AUTO-FILL CHAMBER AND EXTRA LIMB.>1.6MIntersurgical IncorporatedBZE2025-03-14
30889483584105AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483588356AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483595842AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483615618AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
10889483616963AirLife™Sunmed Group Holdings, LLCBZE2025-03-07
30889483586529AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587137AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483587328AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483591288AirLife™Sunmed Group Holdings, LLCBZE2025-03-06
30889483572652AirLife™Sunmed Group Holdings, LLCBZE2025-03-05
30889483572904AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483616994AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
10889483617007AirLife™Sunmed Group Holdings, LLCBZE2025-02-27
30889483581043AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581081AirLife™Sunmed Group Holdings, LLCBZE2025-02-21
30889483581135AirLife™Sunmed Group Holdings, LLCBZE2025-02-21