FDA.reportPublic FDA data

HUDSON RCI

Primary DI
10197344007479
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD00040
Catalog number
HUD00040
Device description
AQUAPAK ADAPTER,ALARM,ADAPTER ONLY
Published
2024-02-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
BTTHUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BTTHumidifier, Respiratory Gas, (Direct Patient Interface)Anesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141353000HUDSON RCI AQUAPAK HUMIDIFIER ADAPTORTeleflexmedical, Inc.2014-08-01BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344007476PackageGS1120In Commercial Distribution
10197344007479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734400747620197344007476
1019734400747910197344007479

GMDN Terms#

Term, Definition table
TermDefinition
Oxygen administration/humidifier setA collection of non-sterile devices intended to be used during oxygen (O2) therapy to deliver humidified O2 enriched gas to a patient. It includes both an O2 mask/nasal cannula and a disposable non-prefilled humidifier, and typically the appropriate tubing and connectors; other respiratory equipment (e.g., nebulizer) is not included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
1
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10193489024517MEDLINEMDS601LSQHFEMDS601LSQHFE2026-07-22
10888277348141MEDLINEMDS601P2MDS601P22026-07-22
10884389145517MEDLINEMDS630BSQMDS630BSQ2016-09-27
10884389145722MEDLINEMDS630LSQMDS630LSQ2016-10-14
10884389145739MEDLINEMDS630MSQMDS630MSQ2016-10-14
10884389818794MEDLINEMDS630XSQMDS630XSQ2016-09-27
20080196162410MEDLINEMPHADJDEPTH2MPHADJDEPTH22023-01-21
10080196395811MEDLINEMPH100030MPH1000302026-07-22
10653160393979MEDLINEDYNDC3596DYNDC35962026-07-21
10653160394051MEDLINEDYNDC3606DYNDC36062026-07-21
10653160394082MEDLINEDYNDC3613DYNDC36132026-07-21
10653160394099MEDLINEIV8880AIV8880A2026-07-21
10653160394105MEDLINEECVC8651ECVC86512026-07-21
10653160394112MEDLINEDYNDC3597DYNDC35972026-07-21
10653160394129MEDLINEDYNDC3611DYNDC36112026-07-21
10653160394150MEDLINEDYNDJ1156DYNDJ11562026-07-21
10653160394167MEDLINEDYNDV2742ADYNDV2742A2026-07-21
10653160394174MEDLINEECVC8390CECVC8390C2026-07-21
10653160394181MEDLINEEBSI1477CEBSI1477C2026-07-21
10653160394211MEDLINEDYNDC3605DYNDC36052026-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
09420012474643F&P 850FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-13
09420012425911Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012425928Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012430410Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012449818Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012465849Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012471918Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-03-18
09420012481740F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481795F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
09420012481818F&P Optiflow Switch+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-02-25
10197344005994HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-02-02
10197344009725HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-01-26
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
10197344009596HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-10-17
10197344009589HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-08-18
10197344009817HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2025-04-05
10193489149296HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-11-22
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
09420012461452F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012461469F&P Optiflow Junior 2FISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476555F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476579F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012476593F&P Optiflow SwitchFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
09420012477910F&P Optiflow THRIVEFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-09-11
10193489149302HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
10193489149562HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-05-01
09420012463814Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-04-30
09420012474155Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2024-04-30