FDA.reportPublic FDA data

HUDSON RCI

Primary DI
10197344009862
Brand
HUDSON RCI
Company
MEDLINE INDUSTRIES, INC.
Model
HUD241212
Catalog number
HUD241212
Device description
CANNULA, ADULT, COMFORT FLO PLUS, MEDIUM
Published
2025-08-21
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
K240163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240163000Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaMedline Industries, LP2024-09-27BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20197344009869PackageGS120In Commercial Distribution
10197344009862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2019734400986920197344009869
1019734400986210197344009862

GMDN Terms#

Term, Definition table
TermDefinition
Nasal oxygen cannula, basic"A semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with a headstrap, to administer oxygen (O2). It is commonly known as ""nasal prongs"". This is a single-use device."

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep dry. Keep away from sunlight.

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
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10080196320899MEDLINEMDS30310MDS303102026-09-25
10080196321407MEDLINEMDS30605MDS306052026-09-25
10080196321414MEDLINEMDS30607MDS306072026-09-25
10080196321438MEDLINEMDS30803MDS308032026-09-25
10080196321452MEDLINEMDS30805MDS308052026-09-25
10080196321469MEDLINEMDS30806MDS308062026-09-25
10080196321476MEDLINEMDS30807MDS308072026-09-25
10080196321483MEDLINEMDS30808MDS308082026-09-25
10080196321490MEDLINEMDS30809MDS308092026-09-25
10198459754210MEDLINEVASC1970VASC19702026-09-25
10198459754524MEDLINEVASC1971VASC19712026-09-25
10198459755699MEDLINEVASC1959VASC19592026-09-25
10198459755705MEDLINEVASC1962VASC19622026-09-25
10198459758287MEDLINEVASC1974VASC19742026-09-25
10198459758294MEDLINEVASC1975VASC19752026-09-25
10198459759291MEDLINEVASC1976VASC19762026-09-25
10198459760846MEDLINEVASC1977VASC19772026-09-25
10198459761850MEDLINEVASC1978VASC19782026-09-25
10198459766336MEDLINEVASC1979VASC19792026-09-25
10198459771224MEDLINEVASC1980VASC19802026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10197344010813HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-09-21
10197344016884HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016891HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016938HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016945HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016969HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016976HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016983HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
10197344016990HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2026-08-27
00841737100775Vapotherm Inc.VAPOTHERM, INC.BTT2026-06-23
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09420012430410Fisher & Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2026-04-08
09420012480729F&P OptiflowFISHER & PAYKEL HEALTHCARE LIMITEDBTT2025-11-07
00810083350561SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
00810083350585SENSIMEDICAL Sterile Water for Inhalation, USPSensimedical LLCBTT2025-10-06
10889483570906AirLife™AIRLIFEBTT2025-02-20
10889483570913Airlife™ Bubble Humidifier with 6 psi Pressure Relief ValveAIRLIFEBTT2025-02-20
10889483571477Airlife™ Sterile Water for Inhalation, USP, 500 mlAIRLIFEBTT2025-02-20
10197344009749HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-10-31
10197344009756HUDSON RCIMEDLINE INDUSTRIES, INC.BTT2024-09-24
07640140860749Monsoon III Laserjet 70Acutronic Medical Systems AGBTT2023-01-20
00810071637285CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
00810071637292CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
00810071637308CuraplexBOUND TREE MEDICAL, LLCBTT2022-12-30
09420012416179Fisher and Paykel HealthcareFISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012428493F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429117F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429155F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02
09420012429711F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02