HUDSON RCI 41894

GUDID 24026704671032

NEBULIZER W/PED MASK & TBG, SMALL VOLUME

TELEFLEX INCORPORATED

Nebulizing system, non-heated

• Primary Device ID: 24026704671032
• NIH Device Record Key: 8d2ce13a-5760-422d-b045-e9b9e0704e19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HUDSON RCI
• Version Model Number: IPN914805
• Catalog Number: 41894
• Company DUNS: 002348191
• Company Name: TELEFLEX INCORPORATED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
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• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM
• Phone: +1(919)544-8000
• Email: CS@TELEFLEX.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	14026704671035 [Primary]
GS1	24026704671032 [Package]; Contains: 14026704671035; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K930525

FDA Product Code

• CAF: NEBULIZER (DIRECT PATIENT INTERFACE)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-12-18
• Device Publish Date: 2019-12-10

On-Brand Devices [HUDSON RCI]

• 44026704595912: MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• 24026704597424: ADDIPAK 0.9% NaCl for Inhalation USP, 15 mL
• 14026704595911: MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• 14026704595546: METERED DOSE INHALER ADPTR,15MMIDX15MMOD
• 14026704595041: AEROSOL TEE CONNECTOR
• 14026704595034: Disposable Thermometer with Thermometer Adaptor
• 14026704595027: Disposable Thermometer Adaptor
• 14026704594990: Pressure Line Adaptor
• 14026704594952: Nebulizer Tee Connector
• 14026704594730: Multi Adaptor 15 mm I.D. / 22 mm O.D.
• 14026704594723: Universal Cuff Adaptor 22 mm I.D.
• 14026704594327: Ventilator Adaptor Elbow Elbow Connections - 15 mm I.D x 22 mm O.D. Section Port - 11.5 mm O.D.
• 34026704581925: Adaptor, Elbow, 22mm
• 34026704581918: Temperature/Pressure Tee 22mm
• 14026704580320: ETCO2 CANNULA,LARGE
• 14026704390271: Trache T Oxygenator
• 14026704390172: Pressure Line Adaptor
• 14026704390165: Tubing Connector
• 14026704390141: DISPOSABLE THERMOMETER,INTL
• 14026704390066: Multi Adaptor
• 14026704390059: Universal Cuff Connector
• 14026704610393: SOFTECH BI-FLO Cannula w/ Gas Sampling Line (Famale Luer Connector)
• 24026704598346: 90 DEG ADAPTER, 22MM ODX 22MM ID (OSMO)
• 24026704597295: AQUAPAK 0.45% NaCl for Inhalation 440 mL w/ 033 Nebulizer Adaptor
• 24026704597288: AQUAPAK 0.45% NaCl for Inhalation 440 mL w/ 028 Nebulizer Adaptor
• 24026704597271: AQUAPAK Sterile Water for Inhalation 440 mL w/ 033 Nebulizer Adaptor
• 24026704597264: AQUAPAK Sterile Water for Inhalation 440 mL w/ 028 Nebulizer Adaptor
• 24026704597257: AQUAPAK 0.45% NaCl for Inhalation 1070 mL w/ 028 Nebulizer Adaptor
• 24026704597240: AQUAPAK Sterile Water for Inhalation 1070 mL w/ 033 Nebulizer Adaptor
• 24026704597233: AQUAPAK Sterile Water for Inhalation 1070 mL w/ 028 Nebulizer Adaptor
• 24026704597202: AQUAPAK 0.45% NaCl for Inhalation 760 mL w/ 033 Nebulizer Adaptor
• 24026704597196: AQUAPAK 0.9% NaCl for Inhalation 760 mL w/ 028 Nebulizer Adaptor
• 24026704597189: AQUAPAK 0.45% NaCl for Inhalation 760 mL w/ 028 Nebulizer Adaptor
• 24026704597172: AQUAPAK Sterile Water for Inhalation 760 mL w/ 033 Nebulizer Adaptor
• 24026704597165: AQUAPAK Sterile Water for Inhalation 760 mL w/ 028 Nebulizer Adaptor
• 24026704596663: 7 ft. Star Lumen® Tubing with Two Hose Ends, Bulk
• 24026704594836: Venti-Comp
• 14026704589774: SOFTECH® Plus ETCO2 Cannula
• 14026704589767: SOFTECH® Plus ETCO2 Cannula
• 14026704589750: SOFTECH® Plus ETCO2 Cannula
• 14026704589743: SOFTECH® Plus ETCO2 Cannula
• 14026704589712: SOFTECH® Plus ETCO2 Cannula
• 24026704582185: Manifold Adaptor
• 24026704582161: RACCORDO ELBOW PORTA RESISTENZA
• 24026704582154: ELBOW, HTD WIRE, 22MM, 60 DEG.
• 24026704581928: Adaptor, Elbow, 22mm
• 24026704581911: Temperature/Pressure Tee 22mm
• 24026704581904: ELBOW, HTD WIRE, 15MM, 60 DEGREES
• 24026704581898: ELBOW, HTD WIRE, 15MM, 60 DEGREES
• 24026704581881: Adaptor, 15mm / 22mm