TRUER MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2032273	3003240904	TRUER MEDICAL, INC.	1	N	2026-01-01	1050 N Batavia St Ste C ORANGE CA US 92867

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00859290006359	Pediatric Stylet - The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.	7146289785	ttruitt@truermedical.com
00859290006441	400 Series Right Angle Cable (80 cm) - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipmen	7146289785	ttruitt@truermedical.com
00859290006458	400 Series Right Angle Cable (160 cm) - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipmen	714 628-9785	ttruitt@truermedical.com

truermedical.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
58343	1251428751	K101244	SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE	FLL	2010-11-18
58343	1859613112	K092716	ESOPHAGEAL STETHOSCOPE	BZT	2009-09-17
58343	1858697755
58343	1066856797
58343	1354453666
58343	1421377002
58343	1770517683
58343	1771354737
58343	1961514419

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
FLL	1	2010-11-18
BZT	1	2009-09-17

GUDID#

Sharn by Marketlab - The Sharn by Marketlab Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Sharn by Marketlab Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps.
TRUER MEDICAL, INC.
2024-10-29
Sharn by Marketlab - The Sharn by Marketlab Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Sharn by Marketlab Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps.
TRUER MEDICAL, INC.
2024-10-29
HP to 3.5mm Phonojack Cable with Shrinkwrap - 70309
TRUER MEDICAL, INC.
2024-01-16
Truer Bougie Coiled - Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
TRUER MEDICAL, INC.
2023-09-22
Truer Bougie Coiled - Truer Medical’s new Bougie is a latex-free, calibrated introducer designed to ensure accurate distance insertion.
TRUER MEDICAL, INC.
2023-09-22
400 Series Right Angle Cable (80 cm) - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipmen
TRUER MEDICAL, INC.
2023-07-19
400 Series Right Angle Cable (160 cm) - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipmen
TRUER MEDICAL, INC.
2023-07-19
Pediatric Stylet - The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.
TRUER MEDICAL, INC.
2022-06-30
Adult Stylet - The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.
TRUER MEDICAL, INC.
2022-06-30
CO EX LINE 96'X.048'X112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials
TRUER MEDICAL, INC.
2022-12-09
Nasal Cannula - Adult Nasal Cannula w/7' safety channel tubing
TRUER MEDICAL, INC.
2022-09-08
Nasal Cannula - Adult Nasal Cannula w/7' safety channel tubing
TRUER MEDICAL, INC.
2022-09-08
Truer Bougie - Truer Medical’s new Bougie is a latex free, calibrated introducer designed to ensure accurate distance insertion. Truer Medical’s Bougie is the most adaptable, cost effective bougie available in the market. Low density polyethylene frosted finish sheath reduces friction and provides proper stiffness for ease of insertion. Multiple depth marks and malleable for straight or coudé tip.
TRUER MEDICAL, INC.
2022-08-29
Gas Sampling Line 120'x.048'x.108' M/F - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Gas Sampling Line 120'x.040'x.112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Gas Sampling Line 120'X.050'x.108' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 120'x.050'x.108' M/F - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 96'x.050'x.112' MM - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 120' X .050' X .112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Gas Sampling Line 120 x .048 x .108 M/M CO-EX - Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit.
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 120'X.060'X.112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
HP 400 series type monitor cable - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipment.
TRUER MEDICAL, INC.
2022-07-06
400 Series Type Monitor Cable, Right Angle - Truer Medical Temperature Monitoring Interface Cables offer several different interface configurations. By standardizing temperature probes and using an interface cable, inventory can be reduced while maintaining compatibility with most monitoring equipment.
TRUER MEDICAL, INC.
2022-07-06
Gas Sampling Line 120'x.048'x.108' M/F - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Gas Sampling Line 120'x.040'x.112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Gas Sampling Line 120'X.050'x.108' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 120'x.050'x.108' M/F - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 96'x.050'x.112' MM - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
GAS SAMPLING LINE 120' X .050' X .112' M/M - Truer Medical Gas Sampling Lines are manufactured to the highest quality standards using medical-grade materials. Standard luer connection ensures secure fit
TRUER MEDICAL, INC.
2022-06-30
Pediatric Stylet - The Truer Medical disposable Intubation Stylet is the most adaptable, cost-effective stylet available on the market. Each stylet contains malleable wire encased in a specially designed PVC sheath which allows the Truer Medical Stylet to be used in a wide range of Endotracheal Tube (ETT) sizes while still maintaining the shape you require. With just two stylet sizes in your inventory, all ETT sizes are covered, simplifying inventory control and ordering. A unidirectional end cap doesn’t permit the stylet to advance forward during the intubation process, significantly lowering the risk of unnecessary trauma to the patient. Simply install the stylet into the ETT and engage the unidirectional end cap onto the 15mm ETT connector. Draw the frosted PVC coated wire back to the desired location, shape the ETT, and you are ready to intubate. This assures a procedure that is fast, efficient, and—most importantly—safe.
TRUER MEDICAL, INC.
2022-06-30
Adult Headstrap - The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual.
TRUER MEDICAL, INC.
2022-06-30
Pediatric Headstrap - The Truer Medical Head Strap features two sleek designs to accommodate adult and child sizes which provide an even distribution of pressure to ensure maximum comfort. With minimal spacing between the holes on the straps, these designs allow for a wide range of locations to secure the straps to any sized individual.
TRUER MEDICAL, INC.
2022-06-30
QuickSplint Kit Pouch - The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch.While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
2017-06-01
Orofacial Therapeutics - The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch.While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
2017-06-01
Truer Medical, Inc. - The Truer Medical Skin Temperature Sensor is designed for monitoringa patient’s skin surface temperature during surgical procedures,postoperative recovery, or whenever a clinician needs to accuratelyassess patient skin temperature. The Truer Medical, Inc. Skin Sensorhas reflective silver material on one side to insulate the sensor fromheat generated by operating room lights or heat lamps.
TRUER MEDICAL, INC.
2016-08-04
Truer Medical, Inc. - The Truer Medical Skin Temperature Sensor is designed for monitoringa patient’s skin surface temperature during surgical procedures,postoperative recovery, or whenever a clinician needs to accuratelyassess patient skin temperature. The Truer Medical, Inc. Skin Sensorhas reflective silver material on one side to insulate the sensor fromheat generated by operating room lights or heat lamps.
TRUER MEDICAL, INC.
2016-08-04
Truer Medical, Inc. - The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor is used in a surgical setting for monitoring temperature, as well as,heart and lung sounds of anesthetized patients. Inserted in the esophagus,the stethoscope provides an accurate measurement of core bodytemperature, as well as, transmitting clear heart and lung sounds to theanesthesiologist.
TRUER MEDICAL, INC.
2016-06-06
QuickSplint Kit Pouch - The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
TRUER MEDICAL, INC.
2017-06-01
Truer Medical, Inc. - The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor is used in a surgical setting for monitoring temperature, as well as,heart and lung sounds of anesthetized patients. Inserted in the esophagus,the stethoscope provides an accurate measurement of core bodytemperature, as well as, transmitting clear heart and lung sounds to theanesthesiologist.
TRUER MEDICAL, INC.
2016-06-06
Truer Medical, Inc. - The Truer Medical disposable Esophageal Stethoscope with TemperatureSensor is used in a surgical setting for monitoring temperature, as well as,heart and lung sounds of anesthetized patients. Inserted in the esophagus,the stethoscope provides an accurate measurement of core bodytemperature, as well as, transmitting clear heart and lung sounds to theanesthesiologist.
TRUER MEDICAL, INC.
2016-06-06

55 records. Showing 1-40. Next