FDA.reportPublic FDA data

HUDSON RCI

Primary DI
14026704628282
Brand
HUDSON RCI
Company
TELEFLEX INCORPORATED
Model
IPN049222
Catalog number
385-30
Device description
CONCHAPAK Sterile Water, 1650 mL w/ Low Compliance Vertical Port Column
Published
2019-05-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K820878000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820878000CONCHO PEDIATRIC PACKRci, Inc.1982-05-03BTT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04026704597628PreviousGS10
14026704628282PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04026704597628040267045976284026704597628
1402670462828214026704628282

GMDN Terms#

Term, Definition table
TermDefinition
Inhalation therapy sterile waterA quantity of sterile water (H2O) intended to prevent the drying of airway passages associated with a dry environment or the inhalation of medical gases. It is typically used with various types of inhalation therapy devices (e.g., humidifiers, nebulizers, oxygen therapy delivery systems) to increase the humidity of respired air through the addition of vaporized/atomized water to room air or to the gas stream of a breathing circuit. The water contains no additional solutes, is typically available in a plastic container of various sizes, and may be provided with an adaptor for connecting to the inhalation therapy device. After application, it cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
002348191
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10801902172065ARROWIPN917285IAP-07002021-09-27
10801902187649ARROWIPN919474CS-12123-F2022-11-29
10801902215229ARROWIPN928089CS-12123-F2023-06-05
14026704633002DEKNATELIPN02854479-5562019-09-03
14026704633019DEKNATELIPN02854579-5602019-09-04
14026704633026DEKNATELIPN02854679-5982019-09-04
14026704633149DEKNATELIPN02855779-7752019-09-04
14026704633156DEKNATELIPN02855879-8122019-09-04
14026704633729DEKNATELIPN028759RC6-9702019-09-04
14026704633828DEKNATELIPN028581X-21612019-09-04
14026704633842DEKNATELIPN028658X-29722019-09-03
14026704633873DEKNATELIPN028583X-30192019-09-04
14026704633880DEKNATELIPN028763X-30272019-09-04
14026704633897DEKNATELIPN028764X-30942019-09-04
14026704633910DEKNATELIPN028584X-31422019-09-04
14026704633934DEKNATELIPN028766X-33412019-09-04
14026704633996DEKNATELIPN028769X-36342019-09-04
14026704634047DEKNATELIPN028773X-41942019-09-04
14026704634108DEKNATELIPN028661X-44342019-09-04
14026704634399DEKNATELIPN028776X-48842019-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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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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
09420012429735F&P Optiflow+FISHER & PAYKEL HEALTHCARE LIMITEDBTT2022-08-02