Salaera, LLC d.b.a Maxtec

Registration Details

Registration Name: Salaera, LLC d.b.a Maxtec
Registration Number: 1722070
FEI Number: 1000117260
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 2305 S 1070 W
City: Salt Lake City
State: UT
ZIP: 84119
Country: US

Regulatory Submissions

510(k) Number: K113232

Owner / Operator

Firm Name: Salaera, LLC d.b.a Maxtec
Operator Number: 9042996
Address: 2305 South 1070 West
City: Salt Lake City
State: UT
Postal Code: 84119
Country: US
Correspondent: Anvitha Anand Rao

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	Class 2	Anesthesiology	No	2012-03-05
Tubing, Pressure And Accessories	BYX	Class 1	Anesthesiology	No	2010-01-04
Oximeter	DQA	Class 2	Cardiovascular	No	2014-06-26
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	Class 2	Anesthesiology	No	2010-03-22
Laryngoscope, Rigid	CCW	Class 1	Anesthesiology	No	2017-12-14
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	Class 2	Anesthesiology	No	2018-12-05
Ventilator, Continuous, Facility Use	CBK	Class 2	Anesthesiology	No	2014-12-10
Transducer, Gas Flow	BXP	Class 1	Anesthesiology	No	2021-12-20
Spirometer, Monitoring (W/Wo Alarm)	BZK	Class 2	Anesthesiology	No	2014-01-27
Filter, Bacterial, Breathing-Circuit	CAH	Class 2	Anesthesiology	No	2014-01-27
Hood, Oxygen, Infant	FOG	Class 1	Anesthesiology	No	2004-09-14
Flowmeter, Calibration, Gas	BXY	Class 1	Anesthesiology	No	2017-07-19
Oximeter, Ear	DPZ	Class 2	Cardiovascular	No	2018-12-05
Stand, Infusion	FOX	Class 1	General Hospital	No	2010-01-04
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	Class 2	Anesthesiology	No	2014-03-28
System, Thermal Regulating	DWJ	Class 2	Cardiovascular	No	2015-05-12
Flowmeter, Tube, Thorpe, Back-Pressure Compensated	CAX	Class 1	Anesthesiology	No	2014-03-28
Pad, Neonatal Eye	FOK	Class 1	General Hospital	No	2004-09-14
Tape And Bandage, Adhesive	KGX	Class 1	General Hospital	No	2020-02-07

Proprietary Names

MaxFlo2 Mini MaxFLO2 High and Low Flow Mixing Blocks / MaxMixing Block Air/Oxygen Straight and Coiled Hoses 2-in-1 and 3-in-1 Adapters Blender Buddy Blend-Up Accessory Kit BlenderBuddy2 M800 Pulse Oximeter TEC Oxygen Sensors APA(TM) DAB (clean, non-sterile); APA(TM) DAB (sterile); APA(TM) Handle and APA(TM) Camera Module; APA(TM) MAC 3 Blade ( NAPA LP 15 MaxO2 Vent M70A and M70C Pulse Oximeter Exhalometer MaxO2ME SUPERDOME Stand Alone Acrylic Flowmeter MicroMax - Low and High Flow Microblenders Mysign S 03920A LOW FLOW AIR/OXYGEN MICROBLENDER Bird MicroBlender MaxBlend2+p Max-250MKT Max-250 + Max-250TM Max-250TL Max-250K Max-250MST Max-250E Max-250MS Max-250 XPCB Max-250A Max-250TE Max-250SLE Max-250TA Maxtec Oxygen Sensors Max-250MK MAX-250TEL MaxBlend 2 Sentry 2 Stand, SmartStack Stand, SmartStack and Universal Tray UltraMaxO2 Oxygen Analyzer FloCap CO2 Indicator Max02 Tecotherm and Tecotherm Supplies Flowmeter Manifold Tec Oxygen Analyxers and Monitors MaxBlend High and Low Flow Blenders EYEMAX OM-25A OM-25ME OM-25RMEI OM-25MEL OM-25RME OM-25AE ITS Novo Main-Lock Set MaxVenturi OptiVenturi MaxO2ME+P M700 Pulse Oximeter M70 Pulse Oximeter Handi SPO2 Probes Mysign O

Establishment Types

Manufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Complaint File Establishment per 21 CFR 820.198