Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube With Salter Flex-Tip And Salter ThinCuff
Salter Labs, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004748541 | 3004748541 | Salter Labs | 1 | Y | 2026-01-01 | 30 Spur Drive El Paso TX US 79906 |
| 3010272829 | 3010272829 | Salter Labs de Mexico de S.A. de C.V. | 1 | N | 2026-01-01 | Blvd. Independencia #2167 Parque Ind. Las Americas - Horizonte Sur. Cd. Ju Chihuahua Mexico MX 32596 |
| 3000219639 | 3000219639 | Salter Labs | 1 | N | 2020-04-25 | 2365 Camino Vida Roble Carlsbad CA US 92011 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 10607411007344 | Sticky Whiskers - Sticky-Whiskers Securement Device for infants | +1(800)421-0024 | customercare@salterlabs.com |
| 10607411950503 | AirLife⢠- Salter LabsTM Oxygen Tubing with 2 standard connectors, 1' (.3 m) | 1-800-433-2797 | info@sun-med.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 137244 | 1346476732 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | 1999-09-24 |
| 155615 | 1346476732 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | 1999-09-24 |
| 161282 | 1346476732 | K992986 | SALTER LABS SINGLE PATIENT USE EXHALATION AEROSOL FILTER | CAF | 1999-09-24 |
| 137244 | 1981047792 | K992285 | SALTER AIRE COMPRESSOR | CAF | 2000-01-07 |
| 155615 | 1981047792 | K992285 | SALTER AIRE COMPRESSOR | CAF | 2000-01-07 |
| 161282 | 1981047792 | K992285 | SALTER AIRE COMPRESSOR | CAF | 2000-01-07 |
| 137244 | 1594787648 | K991788 | SALTER LABS PEP DEVICE | CAF | 1999-08-06 |
| 155615 | 1594787648 | K991788 | SALTER LABS PEP DEVICE | CAF | 1999-08-06 |
| 161282 | 1594787648 | K991788 | SALTER LABS PEP DEVICE | CAF | 1999-08-06 |
| 155615 | 1605086157 | K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) | NFB | 1999-05-07 |
| 161282 | 1605086157 | K990678 | PNEUMATIC DEMAND OXYGEN CONSERVER (PDOC) | NFB | 1999-05-07 |
| 137244 | 1459903812 | K990659 | NASAL AIRE | BZD | 1999-11-26 |
| 137244 | 1618903930 | K984528 | PARKER FLEX-TIP TRACHEAL TUBE | BTR | 1999-07-15 |
| 155615 | 2057405672 | K983500 | PRO2 CHECK OXYGEN INDICATOR | CCL | 1999-03-17 |
| 161282 | 2057405672 | K983500 | PRO2 CHECK OXYGEN INDICATOR | CCL | 1999-03-17 |
| 137244 | 1204126106 | K983467 | THERAPEP | BWF | 1999-04-02 |
| 155615 | 1204126106 | K983467 | THERAPEP | BWF | 1999-04-02 |
| 161282 | 1204126106 | K983467 | THERAPEP | BWF | 1999-04-02 |
| 137244 | 1107479341 | K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | CAF | 1998-12-17 |
| 155615 | 1107479341 | K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | CAF | 1998-12-17 |
| 161282 | 1107479341 | K983403 | SALTER LABS NEBULIZER EXHALATION AEROSOL FILTER | CAF | 1998-12-17 |
| 137244 | 1213774787 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | 1996-10-22 |
| 155615 | 1213774787 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | 1996-10-22 |
| 161282 | 1213774787 | K962879 | SALTERLABS 8660 SERIES NEBULIZER | CAF | 1996-10-22 |
| 137244 | 1120519877 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | 1996-07-16 |
| 155615 | 1120519877 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | 1996-07-16 |
| 161282 | 1120519877 | K961476 | SALTERLABS 8960 SERIES NEBULIZER (8960/8961/8966/8984) | CAF | 1996-07-16 |
| 137244 | 1101129182 | K952713 | MINI WRIGHT LR AFS | BZH | 1996-03-29 |
| 155615 | 1101129182 | K952713 | MINI WRIGHT LR AFS | BZH | 1996-03-29 |
| 161282 | 1101129182 | K952713 | MINI WRIGHT LR AFS | BZH | 1996-03-29 |
| 137244 | 1870602980 | K930957 | ZEFON GAS SAMPLING LINES | CCK | 1993-07-02 |
| 155615 | 1870602980 | K930957 | ZEFON GAS SAMPLING LINES | CCK | 1993-07-02 |
| 161282 | 1870602980 | K930957 | ZEFON GAS SAMPLING LINES | CCK | 1993-07-02 |
| 137244 | 1025950057 | K921997 | CUFF-M | DXQ | 1992-07-23 |
| 155615 | 1025950057 | K921997 | CUFF-M | DXQ | 1992-07-23 |
| 161282 | 1025950057 | K921997 | CUFF-M | DXQ | 1992-07-23 |
| 137244 | 1691124078 | K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | CAT | 1991-10-18 |
| 155615 | 1691124078 | K913421 | NASAL OXYGEN CANNULA, 81585, 81587 & 81589 | CAT | 1991-10-18 |
| 137244 | 1349388522 | K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | BYG | 1991-07-19 |
| 155615 | 1349388522 | K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | BYG | 1991-07-19 |
| 161282 | 1349388522 | K912633 | SALTER LABS INFANT MEDIUM CONCENTRATION MASK | BYG | 1991-07-19 |
| 137244 | 1619398572 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | 1991-07-24 |
| 155615 | 1619398572 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | 1991-07-24 |
| 161282 | 1619398572 | K911740 | SALTER LABS NEONATAL NASAL OXYGEN CANNULA | CAT | 1991-07-24 |
| 137244 | 1490923994 | K903539 | SALTER LABS MODEL #1015 | CBH | 1990-12-17 |
| 155615 | 1490923994 | K903539 | SALTER LABS MODEL #1015 | CBH | 1990-12-17 |
| 161282 | 1490923994 | K903539 | SALTER LABS MODEL #1015 | CBH | 1990-12-17 |
| 137244 | 1012762025 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | 1987-03-16 |
| 155615 | 1012762025 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | 1987-03-16 |
| 161282 | 1012762025 | K870027 | HAND HELD PHEUMATIC POWERED (DISPOSABLE) NEBULIZER | CCQ | 1987-03-16 |
| 137244 | 1309874379 | K863656 | SALTER VOLUCHEK 6600 | BZG | 1986-10-06 |
| 155615 | 1309874379 | K863656 | SALTER VOLUCHEK 6600 | BZG | 1986-10-06 |
| 161282 | 1309874379 | K863656 | SALTER VOLUCHEK 6600 | BZG | 1986-10-06 |
| 137244 | 1338909484 | K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | CAT | 1986-09-18 |
| 155615 | 1338909484 | K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | CAT | 1986-09-18 |
| 161282 | 1338909484 | K863432 | OXYGEN CANNULA EAR WRAP (STYLE B) | CAT | 1986-09-18 |
| 137244 | 1792208592 | K772127 | OXYGEN MASK, AIR-ENTRAINMENT | BYF | 1978-01-03 |
| 155615 | 1792208592 | K772127 | OXYGEN MASK, AIR-ENTRAINMENT | BYF | 1978-01-03 |
| 161282 | 1792208592 | K772127 | OXYGEN MASK, AIR-ENTRAINMENT | BYF | 1978-01-03 |
| 137244 | 1209759398 | K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff | BTR | 2020-01-10 |
| 137244 | 1878033663 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | 2016-12-14 |
| 155615 | 1878033663 | K162343 | Westmed Gas Sampling Cannula with O2 delivery | CCK | 2016-12-14 |
| 137244 | 1206232911 | K161719 | Salter Labs Bubble Humidifier | BTT | 2017-09-21 |
| 155615 | 1206232911 | K161719 | Salter Labs Bubble Humidifier | BTT | 2017-09-21 |
| 161282 | 1206232911 | K161719 | Salter Labs Bubble Humidifier | BTT | 2017-09-21 |
| 137244 | 1382614866 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | 2016-04-15 |
| 155615 | 1382614866 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | 2016-04-15 |
| 161282 | 1382614866 | K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor with Airflow Pressure Cannulas, Nasal and Oral/Nasal | MNR | 2016-04-15 |
| 137244 | 1727722129 | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | 2016-03-11 |
| 155615 | 1727722129 | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | 2016-03-11 |
| 161282 | 1727722129 | K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula | NFB | 2016-03-11 |
| 137244 | 1553698209 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | 2016-03-10 |
| 155615 | 1553698209 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | 2016-03-10 |
| 161282 | 1553698209 | K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines | CCK | 2016-03-10 |
| 137244 | 1769258570 | K143700 | CPAP Cannulaide | BZD | 2015-08-05 |
| 155615 | 1769258570 | K143700 | CPAP Cannulaide | BZD | 2015-08-05 |
| 161282 | 1769258570 | K143700 | CPAP Cannulaide | BZD | 2015-08-05 |
| 137244 | 1367667577 | K142416 | Luma Wrap | PDH | 2015-06-12 |
| 155615 | 1367667577 | K142416 | Luma Wrap | PDH | 2015-06-12 |
| 161282 | 1367667577 | K142416 | Luma Wrap | PDH | 2015-06-12 |
| 137244 | 1048709595 | K133806 | M1 CAPNOGRAPHY MASK | CCK | 2013-12-31 |
| 155615 | 1048709595 | K133806 | M1 CAPNOGRAPHY MASK | CCK | 2013-12-31 |
| 137244 | 1979202012 | K121743 | EASYMED PERIPHERAL NERVE STIMULATOR-SUNSTIN | BXN | 2013-03-28 |
| 137244 | 2070135332 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | 2012-02-10 |
| 155615 | 2070135332 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | 2012-02-10 |
| 161282 | 2070135332 | K113542 | SALTER LABS BUBBLE HUMIDIFIER (HIGH FLOW) | BTT | 2012-02-10 |
| 137244 | 1565596927 | K100546 | PARKER FLEX- TIP ORAL/NASA INTUBATION TUBE | BTR | 2010-06-03 |
| 137244 | 2024624879 | K092886 | WELL LEAD ENDOBRONCHIAL TUBES | CBI | 2010-03-11 |
| 137244 | 1222442916 | K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | 2009-11-24 |
| 155615 | 1222442916 | K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | 2009-11-24 |
| 161282 | 1222442916 | K092685 | PNEUMOTHERML, MODEL: 5800 | BZQ | 2009-11-24 |
| 137244 | 1556896903 | K082630 | VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES | DXQ | 2008-12-19 |
| 155615 | 1556896903 | K082630 | VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES | DXQ | 2008-12-19 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| CAF | 28 | 2005-02-16 |
| CCK | 13 | 2016-12-14 |
| DXQ | 12 | 2008-12-19 |
| BZD | 10 | 2015-08-05 |
| CAT | 10 | 1991-10-18 |
| BTT | 8 | 2017-09-21 |
| MNR | 7 | 2016-04-15 |
| BZQ | 7 | 2009-11-24 |
| NFB | 6 | 2016-03-11 |
| PDH | 4 | 2015-06-12 |
| BWF | 4 | 1999-04-02 |
| BZH | 4 | 1996-03-29 |
| BYG | 4 | 1991-07-19 |
| CBH | 4 | 1990-12-17 |
| CCQ | 4 | 1987-03-16 |
| BZG | 4 | 1986-10-06 |
| BYF | 4 | 1978-01-03 |
| BTR | 3 | 2020-01-10 |
| CCL | 3 | 1999-03-17 |
| BXN | 1 | 2013-03-28 |
| CBI | 1 | 2010-03-11 |
| CBK | 1 | 2006-08-17 |
| MNS | 1 | 2004-01-14 |
| BTM | 1 | 2001-09-18 |
Salter Labs, Inc.
SALTER LABS
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SALTER LABS, ARVIN FACILITY
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