HUDSON RCI HUD42500
GUDID 10197344010806
NEPTUNE HEATED HUMIDIFIER,CONCHASMART
MEDLINE INDUSTRIES, INC.
Heated respiratory humidifier| Primary Device ID | 10197344010806 |
| NIH Device Record Key | b298715e-c7ce-4341-8065-6c7a44e1ea8b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | HUDSON RCI |
| Version Model Number | HUD42500 |
| Catalog Number | HUD42500 |
| Company DUNS | 025460908 |
| Company Name | MEDLINE INDUSTRIES, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| 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(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com | |
| Phone | +1(800)633-5463 |
| service@medline.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep Dry. |
| Handling Environment Atmospheric Pressure | Between 70 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between -20 Degrees Celsius and 50 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 94 Percent (%) Relative Humidity |
| Handling Environment Temperature | Between 20 Degrees Celsius and 26 Degrees Celsius |
| Handling Environment Humidity | Between 30 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10197344010806 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K131912
FDA Product Code
| BTT | HUMIDIFIER, RESPIRATORY GAS, (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 | 2024-07-10 |
| Device Publish Date | 2024-07-02 |
On-Brand Devices [HUDSON RCI]
| 10197344007226 | AQUAPAK LVN,STRL WATER,760ML,W/ 33 ADAPT |
| 30197344010275 | O2 CANNULA,PEDIATRIC,SOFTECH,7' TUB,SC |
| 30193489149368 | O2 CANN,ADULT,HI-FLO,EAR CUSH,7 TUB,SC |
| 20193489149354 | O2 CANNULA,ADULT,EAR CUSHION,7' TUB,SC |
| 20197344010094 | O2 CANNULA,INFANT,SOFTECH,7' TUB,SC |
| 20197344009906 | O2 CANNULA,ADULT,SOFTECH,25' TUB,UC |
| 20197344009890 | O2 CANNULA,ADULT,SOFTECH,50' TUB,UC |
| 20197344009883 | O2 CANNULA,PEDIATRIC,SOFTECH,7' TUB,UC |
| 20193489149682 | O2 CANNULA,ADULT,SOFTECH,14' TUB,UC |
| 20193489149347 | O2 CANNULA,ADULT,SOFTECH,7' TUB,SC GREEN |
| 20193489149330 | O2 CANNULA,PEDIATRIC,SOFTECH,14' TUB,SC |
| 20193489149323 | O2 CANNULA,PEDIATRIC,SOFTECH,NO TUBING |
| 20193489149316 | O2 CANNULA,ADULT,SOFTECH,4' TUB,SC |
| 20193489149286 | CANNULA,SOFTECH PLUS,PED,14 GRN STAR-LMN |
| 20193489149279 | O2 CANNULA,PEDI,SOFTECH +,7' TUB,UC |
| 20193489149262 | O2 CANNULA,ADULT,SOFTECH +,7' TUB,UC |
| 10197344007202 | AQUAPAK LVN,STRL WATER,440ML,W/ 28 ADAPT |
| 10193489149241 | O2 CANN,ADULT,HI-FLO,EAR CUSH,14 TUB,SC |
| 20197344010285 | O2 CANNULA,ADULT,SOFTECH,50' TUB,SC |
| 20197344009951 | O2 CANNULA,ADULT,SOFTECH,14' TUB,SC |
| 20197344009937 | O2 CANNULA,ADULT,SOFTECH,NO TUBING |
| 20197344009913 | O2 CANNULA,ADULT,SOFTECH,25' TUB,SC |
| 20197344006028 | AQUAPAK LVN,STRL WATER,1070ML,NO ADAPTER |
| 20193489149699 | O2 CANN,ADULT,SOFTECH,7' SMOOTH TUB,SC |
| 20197344010216 | O2 CANNULA,ADULT,SOFTECH +,7' TUB,SC |
| 20197344010209 | O2 CANNULA,PEDIATRIC,SOFTECH +,7' TUB,SC |
| 20197344010193 | O2 CANNULA,INFANT,SOFTECH +,7' TUB,SC |
| 20197344010186 | O2 CANNULA,NEONATAL,SOFTECH +,7' TUB,SC |
| 20197344010179 | O2 CANNULA,ADULT,SOFTECH +,14' TUB,SC |
| 20197344007698 | SPIROMETER,INCENTIVE,TRIFLO II,EXERCISER |
| 20197344010933 | TEMPERATURE PROBE, DISPOSABLE, NEPTUNE |
| 30197344008128 | ADDIPAK SALINE .45%, 3ML, STERILE |
| 20193489149729 | METER,PEAK FLOW,ASTHMAMD,60-810 LPM |
| 20197344009968 | O2 CANNULA,ADULT,SOFTECH,10' TUB,SC |
| 20197344009944 | O2 CANNULA,ADULT,SOFTECH,7' TUB,SC |
| 20197344009920 | O2 CANNULA,ADULT,SOFTECH,7' TUB,UC |
| 20193489149712 | ADAPTER,AEROSOL,NEB,22MM OD X 18MM OD |
| 20193489149675 | ADAPTR, VALVED TEE, 22MM OD/OD X 18MM |
| 20193489149552 | CANNULA, NASAL, INFANT, COMFORT FLO |
| 10197344037384 | NEBULIZER, TURBOMIST, MOUTHPC, 7' TUB SC |
| 10197344037278 | NEB, TRBMST, PED MSK, 7' TUB, SC, XADPT |
| 20197344007476 | AQUAPAK ADAPTER,ALARM,ADAPTER ONLY |
| 20193489138471 | AQUAKPAK BUBBLE HUM,540ML,NO ADAPTER |
| 10197344037407 | NEB, TURBOMIST, MOUTHPIECE |
| 10197344037391 | NEB, TURBOMIST, MTHPC, 7' TUB SC, XADPT |
| 10197344037292 | NEB, TURBOMIST, ADT MSK, LADT, 7' TUB SC |
| 10197344037285 | NEB, TURBOMIST, ADT MSK, LADT, 7' TUB UC |
| 10197344037261 | NEB, TURBOMIST, PED MSK, LADT, 7' TUB SC |
| 10197344037193 | NEB, TURBOMIST, PED MSK, LADT, 7' TUB UC |
| 20197344077561 | NEB, TURBOMIST, CUP ONLY |
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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