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The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution
- 00810335020174 ()
- Infusion pump programmer
Saver EVO is a user friendly information management program to assist users to manage data from their defibrillation device. Saver EVO shall allow the user to download the data from a HeartSine device to a PC computer. Saver EVO™ data management software enables downloading, revie wing and printing ECG waveforms and event history data recorded in HeartSine samaritan PAD devices. Features of Saver EVO include:Comprehensive event documentation to facilitate physician oversight, Utstein style reporting and report export capabilities, User configuration setup and time synchronization, Simple point-and-click operation
HEARTSINE TECHNOLOGIES LTD
1.4.0
In Commercial Distribution
- M727SAVEREVOH013 ()
PAD-ACC-03
- External defibrillator application software
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
36 test
In Commercial Distribution
- 08887581000016 ()
07110888036
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma. It is intended for use as a supplemental (additional, more specific) test for human serum and plasma samples with repeatedly reactive results by an FDA licensed HTLV-I/II donor screening test. The MP Diagnostics HTLV Blot 2.4 is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20. This test is not intended for use in medical diagnosis.
MP BIOMEDICALS ASIA PACIFIC PTE. LTD.
18 test
In Commercial Distribution
- 08887581000009 ()
0711088018
- Human T-cell lymphotrophic virus 1 & 2 (HTLV1 & HTLV2) antibody IVD, kit, immunoblot
OMNI™ II Programmer System (with OMNI Smart Software). System consists of:
(1) OMNI II Programmer (with OMNI Smart Software)
(1) OMNI II Programmer Tablet PC installed with OMNI Smart Programmer Software
(1) OMNI II Programmer Interface Box
(1) OMNI II Programmer Interface Box Cable
(1) Medical-grade Ethernet isolator with Ethernet patch cable
(1) OMNI II Programmer Wand
(1) OMNI II Programmer Wand Extension Cable
(1) USB to Serial Adapter Assembly
(1) Single-lead (3-wire) ECG cable
(1) Medical-grade Power Supply
(1) Medical-grade Power Cord
(1) Bluetooth printer with AC Adapter
(2) Bluetooth printer paper rolls
Impulse Dynamics (usa) Inc.
Programmer System (with OMNI Smart Software)
In Commercial Distribution
- 00810003380012 ()
10-A604-3-US
- Cardiac contractility modulation system programmer
No Description
Biomet Orthopedics, LLC
010002679
In Commercial Distribution
- 00880304551923 ()
- 28MM A
010002679
- Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002680
In Commercial Distribution
- 00880304551916 ()
- 28MM B
010002680
- Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002689
In Commercial Distribution
- 00880304551909 ()
- 32MM B
010002689
- Acetabulum prosthesis trial, prefabricated, reusable
No Description
Biomet Orthopedics, LLC
010002727
In Commercial Distribution
- 00880304551886 ()
010002727
- Orthopaedic implant impactor, reusable
No Description
Biomet Orthopedics, LLC
010002728
In Commercial Distribution
- 00880304551879 ()
010002728
- Orthopaedic implant impactor, reusable