FDA.reportPublic FDA data

HUDSON RCI

Primary DI
04026704582068
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN044281
Catalog number
382-50
Device description
UNIVERSAL CONCHA COLUMN
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KODCATHETER, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KODCatheter, UrologicalGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850335000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850335000URETEROSCOPY CATHETERInmed Corp.1985-03-12KOD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704582062PackageGS148In Commercial Distribution
04026704582068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670458206224026704582062
04026704582068040267045820684026704582068

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.

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902222920ARROWIPN931154CV-15703-E2026-05-20
10801902222937ARROWIPN931155CV-158022026-05-20
10801902222944ARROWIPN931156CV-16702-E2026-05-20
10841495149792QUIKCLOT6366362026-05-18
10841156105907VSIIPN00174679602020-01-27
10841156105914VSIIPN00174979612020-01-27
10841156105921VSIIPN00175279622020-02-06
10841156105938VSIIPN00175679642020-01-27
10841156105945VSIIPN00175979652020-02-06
10841156105952VSIIPN00176379712020-01-27
14026704942456RUSCH221800-000160221800-0001602026-05-15
14026704942463RUSCH221800-000180221800-0001802026-05-15
14026704942470RUSCH221800-000200221800-0002002026-05-15
14026704942487RUSCH221800-000220221800-0002202026-05-15
14026704942494RUSCH221800-000240221800-0002402026-05-15
14026704942500RUSCH221800-000120221800-0001202026-05-15
14026704942517RUSCH221800-000140221800-0001402026-05-15
10801902226096ARROWIPNB00593ASK-15703-BFL2026-05-14
10801902226102ARROWIPNB00594ASK-12703-BFL2026-05-14
14026704921321WECKIPN928663HOL2LG2025-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253024265DoverCardinal Health 200, LLCKOD2026-03-20
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10192253024302DoverCardinal Health 200, LLCKOD2026-03-20
10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
10192253029109DoverCardinal Health 200, LLCKOD2025-04-07
10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253066203DoverCardinal Health 200, LLCKOD2024-09-04
10192253066210DoverCardinal Health 200, LLCKOD2024-09-04
10192253066227DoverCardinal Health 200, LLCKOD2024-09-04
10192253066234DoverCardinal Health 200, LLCKOD2024-09-04
10192253066241DoverCardinal Health 200, LLCKOD2024-09-04
10192253066258DoverCardinal Health 200, LLCKOD2024-09-04
10192253066265DoverCardinal Health 200, LLCKOD2024-09-04