HUDSON RCI 5347
GUDID 34026704662402
Manual Resuscitator, Durable, Infant - with Small Infant (Size 0)Resuscitation Mask and Reservoir
TELEFLEX INCORPORATED
Pulmonary resuscitator, manual, reusable| Primary Device ID | 34026704662402 |
| NIH Device Record Key | 48698adc-72bc-4cc1-8869-626e77a4bb84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HUDSON RCI |
| Version Model Number | IPN039379 |
| Catalog Number | 5347 |
| Company DUNS | 002348191 |
| Company Name | TELEFLEX INCORPORATED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
| CS@TELEFLEX.COM | |
| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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| Phone | +1(919)544-8000 |
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Operating and Storage Conditions
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
| Storage Environment Temperature | Between -40 Degrees Celsius and 60 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04026704613687 [Previous] |
| GS1 | 14026704662408 [Primary] |
| GS1 | 34026704662402 [Package] Contains: 14026704662408 Package: Case [24 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K895589
FDA Product Code
| BTM | Ventilator, emergency, manual (resuscitator) |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
[34026704662402]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-05-13 |
| Device Publish Date | 2019-10-23 |
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 |
Trademark Results [HUDSON RCI]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HUDSON RCI 74158130 1695930 Live/Registered |
TELEFLEX MEDICAL INCORPORATED 1991-04-17 |
 HUDSON RCI 74158129 1753651 Dead/Cancelled |
TELEFLEX MEDICAL INCORPORATED 1991-04-17 |
 HUDSON RCI 74157941 1729000 Live/Registered |
TELEFLEX MEDICAL INCORPORATED 1991-04-17 |
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