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Multi-Parameter Physiological Patient Monitor
DIGICARE BIOMEDICAL TECHNOLOGY, INC.
LW8 Lite
In Commercial Distribution
- 00860003504017 ()
- General-purpose multi-parameter bedside monitor
- Neonatal multi-parameter bedside monitor
TraumaGuard Intra-abdominal Pressure-Sensing Catheter (“TG”). TG is a urine drainage catheter that provides continuous biometric monitoring of Intra-abdominal Pressure (“IAP”) and Core Body Temperature (CBT). TG is a silicone catheter with polyurethane sensing balloons.
IAP UO Temp is also intended for use in the monitoring of intra-abdominal pressure. The measured pressures can be used as an aid in the diagnosis of intra-abdominal hypertension (IAH) and the associated clinical syndrome of abdominal compartment syndrome (ACS). The TraumaGuard Intra-abdominal Pressure-Sensing System Catheter is a single-use device intended for short-term use (less than 30 days).
SENTINEL MEDICAL TECHNOLOGIES
TraumaGuard Intra-abdominal Pressure-Sensing System Single Catheter
In Commercial Distribution
- 00860003478707 ()
000-0219
- Multi-parameter urinary monitoring system catheter set
Lexie Lumen Duo Metalic Black - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Metalic Black
In Commercial Distribution
- 00860003469880 ()
LLO00002MB
- Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Bronze - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Bronze
In Commercial Distribution
- 00860003469866 ()
LLO00002BR
- Air-conduction hearing aid, receiver-in-canal
Lexie Lumen Duo Light Gray - Online
HEARX GROUP (PTY) LTD
Lexie Lumen Duo Light Gray
In Commercial Distribution
- 00860003469842 ()
LLO00002GR
- Air-conduction hearing aid, receiver-in-canal
hearScope consists of a handheld video otoscope with a light source and ear speculum of various sizes that connects to an Android smartphone (can be user-supplied).
HEARX GROUP (PTY) LTD
hearScope
In Commercial Distribution
- 00860003469828 ()
- Otoscope, direct
No Description
HEARX GROUP (PTY) LTD
hearTest
In Commercial Distribution
- 00860003469811 ()
- Tone audiometer
Lexie Lumen self-fitting Beige hearing aid - Duo
HEARX GROUP (PTY) LTD
Lumen Duo Beige
In Commercial Distribution
- 10860003469801 ()
- 00860003469804 ()
Lumen 155
- Air-conduction hearing aid, behind-the-ear
ClearFit VDI Large
LONGEVITI NEURO SOLUTIONS LLC
171718
In Commercial Distribution
- 00860003416310 ()
- Cranial resinous compound
ClearFit VDI Standard
LONGEVITI NEURO SOLUTIONS LLC
171716
In Commercial Distribution
- 00860003416303 ()
- Cranial resinous compound
Fertility Tracking Monitor
Lady Technologies, Inc.
K1
In Commercial Distribution
- 00860003372906 ()
- Natural conception assistance kit
EndoTool is a glucose management software system, designed for use by healthcare professionals in all patient care settings to recommend intravenous and subcutaneous transition dosing, as well as carbohydrates. Evaluating current and cumulative glucose levels, the software adjusts and maintains the glucose level within a configurable clinician-determined target range. The system is indicated for use in adult and pediatric patients ages 2 years and above, who weigh 12 kgs. or more. EndoTool logic is not a substitute for, but rather an adjunct to clinical reasoning. No medical decision should be based solely on the recommended guidance provided by this software system.
MONARCH MEDICAL TECHNOLOGIES LLC
None
In Commercial Distribution
- 00860003340608 ()
- Infusion pump medication-dosage application software
SPIWay Endonasal Access Guide Size Medium
SPIWAY LLC
SP005
In Commercial Distribution
- 00860003136416 ()
- 10860003136413 ()
SP005
- Intranasal splint, non-biodegradable
SPIWay Endonasal Access Guide Size Large
SPIWAY LLC
SP004
In Commercial Distribution
- 00860003136409 ()
- 10860003136406 ()
SP004
- Intranasal splint, non-biodegradable
One handed use
No lancing device required
Automatic needle retraction
Lock out after use prevents needle stick injuries as well as cross-contamination
HOME AIDE DIAGNOSTICS, INC.
PureCSafety100
In Commercial Distribution
- 10860003125561 ()
- 00860003125564 ()
- Needle Gauge: 30 Gauge
- Manual blood lancing device, single-use
Canturio® Smart Extension 14mm (D) x 30mm (H) with Canary Health Implanted Reporting Processor (CHIRP®) system is a tibial extension implant containing electronics
and software.
Canary Medical USA LLC
43-5570-030-14
In Commercial Distribution
- 00860003118399 ()
- Knee femur stem prosthesis
No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution
- 00860003118368 ()
- Medical networking interface unit
The Persona Tibial Keel length ranges from 23.4 mm to 40 mm. The Canary Medical Tibial Extension adds 58 mm to the length of the tibial keel nominally when assembled. This CTE Provisional is used to ensure the fit of the CTE implant within the patient’s anatomy prior to CTE implantation.
Canary Medical USA LLC
43-5571-058-14
In Commercial Distribution
- 00860003118351 ()
- Knee tibia prosthesis trial, reusable
The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution
- 00860003118320 ()
- Medical networking interface unit
The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution
- 00860003118313 ()
- Medical networking interface unit