Hill-Rom Heart And Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart And Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart And Respiration Rate Monitoring System: Sensor Activation
Hill-Rom, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1066635 | 3003184737 | Hill-Rom Company, Inc. | 1 | Y | 2026-01-01 | 4279-U Crosspoint Drive Ladson SC US 29456 |
| 1824206 | 1824206 | HILL-ROM, INC. | 1 | Y | 2026-01-01 | 1069 State Route 46 East Batesville IN US 47006 |
| 2027454 | 2027454 | HILL-ROM, INC. | 1 | N | 2026-01-01 | 1501 Nowell Road Raleigh NC US 27607 |
| 2183816 | 2183816 | HILL-ROM MANUFACTURING, INC. | 1 | N | 2026-01-01 | 1020 COUNTY ROAD F W SAINT PAUL MN US 55126 |
| 3006697241 | 3006697241 | HILL-ROM DE MEXICO S DE RL DE CV | 1 | N | 2026-01-01 | AVE.DEL TELEFONO No. 200 COL. HUINALA APODACA Nuevo Leon MX 66640 |
| 1824206 | 1824206 | HILL-ROM, INC. | 1 | Y | 2020-04-25 | 1069 State Route 46 East Batesville IN US 47006 |
| 2027454 | 2027454 | HILL-ROM, INC. | 1 | N | 2020-04-25 | 1225 CRESCENT GREEN DR. SUITE 300 CARY NC US 27518 |
| 2183816 | 2183816 | HILL-ROM MANUFACTURING, INC. | 1 | Y | 2020-04-25 | 1020 COUNTY ROAD F W SAINT PAUL MN US 55126 |
| 3006697241 | 3006697241 | HILL-ROM DE MEXICO S DE RL DE CV | 1 | N | 2020-04-25 | AVE.DEL TELEFONO No. 200 COL. HUINALA APODACA Nuevo Leon MX 66640 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00615521002848 | ALLEN - Allen® Bow® Frame Skin Care Covers | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00615521031008 | ALLEN - Hug-U-Vac® Standard Lateral Disposable | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00615521031015 | ALLEN - Hug-U-Vac® Large Lateral Disposable | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00615521031022 | ALLEN - Steep Trend Hug-U-Vac® Disposable | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00615521070007 | ALLEN - Allen® Contour™ Cover Kit | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00848340016806 | ALLEN - ARM TRAP | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00887761981720 | Heart and Respiration Rate Monitoring System powered by EarlySense - EarlySense Sensor Assembly | +1(800)445-3730 | us.customerservice@hill-rom.com |
| 00887761985155 | Heart and Respiration Rate Monitoring System powered by EarlySense - EarlySense Sensor Assembly | +1(800)445-3730 | us.customerservice@hill-rom.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 3908 | 1003985454 | K993629 | ABI VEST AIRWAY CLEARANCE SYSTEM | BYI | 2000-01-21 |
| 33176 | 1961044001 | K915779 | AFFINITY BED MODEL 3600 SERIES | KNC | 1993-02-24 |
| 77791 | 1961044001 | K915779 | AFFINITY BED MODEL 3600 SERIES | KNC | 1993-02-24 |
| 301348 | 1928644041 | K250135 | WAVE Clinical Platform (2.0.000) | MWI | 2026-01-16 |
| 301350 | 1086318445 | K233441 | The Vest APX System (PVAPX1) | BYI | 2024-03-22 |
| 301377 | 1949988874 | K223246 | Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense | BZQ | 2022-11-18 |
| 301377 | 1124199158 | K202018 | Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation | BZQ | 2021-03-04 |
| 301350 | 1424471251 | K200988 | Maximus System | NHJ | 2020-05-26 |
| 301377 | 1354688507 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | 2020-06-26 |
| 301379 | 1354688507 | K200723 | StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) | PGW | 2020-06-26 |
| 3908 | 1767516204 | K192143 | Maximus System | NHJ | 2020-02-14 |
| 301350 | 1912065477 | K192143 | Maximus System | NHJ | 2020-02-14 |
| 33176 | 1329383283 | K180079 | Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation | BZQ | 2018-05-07 |
| 301348 | 1303956134 | K171056 | WAVE Clinical Platform | MWI | 2018-01-04 |
| 3908 | 1951177096 | K170037 | Breathe Technologies Life2000™ Ventilation System | CBK | 2017-08-11 |
| 301350 | 1165186955 | K163378 | Monarch Airway Clearance System | BYI | 2017-03-17 |
| 3908 | 2014225634 | K163378 | Monarch Airway Clearance System | BYI | 2017-03-17 |
| 301377 | 1618962092 | K153247 | Fusion Compact Navigation System | PGW | 2016-02-18 |
| 301379 | 1618962092 | K153247 | Fusion Compact Navigation System | PGW | 2016-02-18 |
| 3908 | 1639053740 | K151689 | MetaNeb 4 System | NHJ | 2016-03-17 |
| 301350 | 1928620504 | K151689 | MetaNeb 4 System | NHJ | 2016-03-17 |
| 33176 | 1289291142 | K143414 | Hill-Rom Wireless Connectivity Module | IOQ | 2015-03-10 |
| 301377 | 1839981944 | K143414 | Hill-Rom Wireless Connectivity Module | IOQ | 2015-03-10 |
| 3908 | 1038792434 | K142482 | The Vest Airway Clearance System | BYI | 2015-05-07 |
| 301350 | 1999661390 | K142482 | The Vest Airway Clearance System | BYI | 2015-05-07 |
| 3908 | 1105118268 | K141943 | BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM | CBK | 2015-06-12 |
| 301350 | 2025818617 | K132988 | VITAL COUGH | NHJ | 2014-03-28 |
| 3908 | 1023110398 | K124032 | METANEB | NHJ | 2013-04-25 |
| 301350 | 2067501449 | K124032 | METANEB | NHJ | 2013-04-25 |
| 301377 | 1527560110 | K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | IOQ | 2013-06-03 |
| 33176 | 2072724744 | K122473 | TOTALCARE SPOT TOTALCARE BARIATRIC TOTALCARE DUO TOATALCARE BED SYSTEM TOTALCARE DUO2 | IOQ | 2013-06-03 |
| 3908 | 1703038559 | K120277 | VITAL COUGH | NHJ | 2012-09-12 |
| 33176 | 1987849493 | K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | INK | 2011-09-19 |
| 77791 | 1987849493 | K112502 | PROCEDURAL STRECHER WITH INTELLIDRIVE P8000 | INK | 2011-09-19 |
| 3908 | 1814676448 | K102525 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES (BT-V2S) | ONZ | 2010-12-02 |
| 3908 | 1148353166 | K100528 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S | ONZ | 2010-04-23 |
| 3908 | 1543397542 | K082982 | BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES | ONZ | 2009-07-20 |
| 3908 | 1069915598 | K051964 | POWERNEB | NHJ | 2005-12-01 |
| 301350 | 1239690772 | K051964 | POWERNEB | NHJ | 2005-12-01 |
| 3908 | 1457070830 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | BYI | 2003-02-21 |
| 301350 | 1958919645 | K024309 | THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104 | BYI | 2003-02-21 |
| 301377 | 1370038120 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | HAW | 2000-06-12 |
| 301379 | 1370038120 | K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM | HAW | 2000-06-12 |
| 33176 | 1001823054 | ||||
| 33176 | 1047133778 | ||||
| 77791 | 1047133778 | ||||
| 33176 | 1080749600 | ||||
| 3910 | 1117710013 | ||||
| 33176 | 1119504634 | ||||
| 33176 | 1153939164 | ||||
| 77791 | 1153939164 | ||||
| 33176 | 1200562857 | ||||
| 3908 | 1210950960 | ||||
| 33176 | 1315239730 | ||||
| 77791 | 1315239730 | ||||
| 33176 | 1317319981 | ||||
| 33176 | 1340743187 | ||||
| 33176 | 1357569013 | ||||
| 33176 | 1359884701 | ||||
| 33176 | 1438916203 | ||||
| 33176 | 1525771521 | ||||
| 33176 | 1528244570 | ||||
| 33176 | 1568802517 | ||||
| 33176 | 1583042630 | ||||
| 33176 | 1585647620 | ||||
| 33176 | 1648677433 | ||||
| 33176 | 1781401897 | ||||
| 77791 | 1781401897 | ||||
| 33176 | 1823965178 | ||||
| 33176 | 1946724111 | ||||
| 77791 | 1946724111 | ||||
| 33176 | 1952262688 | ||||
| 3910 | 1953251615 | ||||
| 33176 | 1953477228 | ||||
| 33176 | 1956309006 | ||||
| 77791 | 1956309006 | ||||
| 33176 | 1978157305 | ||||
| 77791 | 1978157305 | ||||
| 33176 | 2001070331 | ||||
| 33176 | 2065818725 | ||||
| 301377 | 1012656338 | ||||
| 301377 | 1048753203 | ||||
| 301379 | 1048753203 | ||||
| 301377 | 1055018430 | ||||
| 301374 | 1146677910 | ||||
| 301377 | 1172917650 | ||||
| 301379 | 1172917650 | ||||
| 301377 | 1207845869 | ||||
| 301379 | 1207845869 | ||||
| 301374 | 1215244120 | ||||
| 301348 | 1244042212 | ||||
| 301374 | 1249052157 | ||||
| 301348 | 1271489774 | ||||
| 301377 | 1376239225 | ||||
| 301377 | 1398476746 | ||||
| 301377 | 1430115081 | ||||
| 301379 | 1430115081 | ||||
| 301374 | 1452390833 | ||||
| 301377 | 1457085441 | ||||
| 301379 | 1457085441 | ||||
| 301374 | 1467048723 | ||||
| 301377 | 1492340253 | ||||
| 301377 | 1500893577 | ||||
| 301379 | 1527560110 | ||||
| 301374 | 1549530289 | ||||
| 301377 | 1554501255 | ||||
| 301377 | 1566847256 | ||||
| 301377 | 1578390532 | ||||
| 301379 | 1578390532 | ||||
| 301377 | 1617971134 | ||||
| 301377 | 1634834473 | ||||
| 301379 | 1634834473 | ||||
| 301374 | 1680330204 | ||||
| 301374 | 1701773594 | ||||
| 301377 | 1789577710 | ||||
| 301379 | 1789577710 | ||||
| 301377 | 1793599190 | ||||
| 301379 | 1793599190 | ||||
| 301374 | 1800411455 | ||||
| 301377 | 1807333690 |
Hill-Rom, Inc.
Hill-Rom Services Pte Ltd
Hill-Rom Services Pte Ltd
Hill-Rom Holdings, Inc.
Hill-Rom Inc.
HILL-ROM SERVICES PTE LTD
Hill-Rom Services Pte Ltd
Hill-Rom Services Private Limited
HILL-ROM
HILL-ROM
HILL-ROM SERVICES PTE LTD
HILL-ROM CO.
HILL-ROM MANUFACTURING, INC.
HILL-ROM MANUFACTURING, INC.
HILL-ROM MANUFACTURING, INC.
HILL-ROM MANUFACTURING, INC.
HILL-ROM AIR-SHIELDS
HILL-ROM AIR-SHIELDS
HILL-ROM AIR-SHIELDS
HILL-ROM AIR-SHIELDS
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
HILL-ROM, INC.
2026-04-24
2026-04-24
2026-04-24
2026-04-24
2026-04-24
2026-04-24
2021-09-23
2018-08-22
2026-04-21
2026-04-20
2026-04-20
2026-04-20
2026-04-20
2026-03-31
2026-03-27
2026-03-27
2026-03-27
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-03-25
2026-02-27
2026-02-19
2026-02-19
2026-02-19
2026-02-19
2026-02-19
2016-09-17
2016-09-17
2023-05-30
2023-06-02
2023-05-30