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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 26mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS-CALIBRATOR CUP 2
In Commercial Distribution

  • 00857088008745 ()
304-3TX

  • Diagnostic x-ray digital imaging system workstation application software
TrackX reusable adapter that enables physicians to calibrate retractors with a distal blade diameter of 21mm with the Calibrator 2.0.
TrackX Technology, LLC
ACCESS 21-ADAPT
In Commercial Distribution

  • 00857088008547 ()
TX-3-4011

  • Diagnostic x-ray digital imaging system workstation application software
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006477 ()

  • Length: 9.25 Inch
  • Width: 4.0 Inch
  • Height: 1.75 Inch
HHRCK01

  • Cricothyrotomy kit, single-use
SWAT-T Elastic Tourniquet, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is orange with black lettering
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006446 ()
  • 00857048006422 ()
SWAT-T-BLK-EA

  • Limb tourniquet, manual, single-use
SWAT-T Elastic Tourniquet, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss.
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006453 ()
  • 00857048006392 ()
SWAT-T-BLK-EA

  • Limb tourniquet, manual, single-use
TK-4L Tourniquet, an elastic tourniquet designed for larger limbs with one S-Hook and one Carabiner end, used to stop or slow severe hemorrhaging from injured limbs and to reduce blood loss. Strap color is black
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006323 ()
TK-4L

  • Limb tourniquet, manual, single-use
H&H Sterile Burn Blanket, a mylar non-adherent sheet sterilized for use in wrapping large burn areas and protecting them from heat and moisture loss.
H&H MEDICAL CORPORATION
1
In Commercial Distribution

  • 00857048006200 ()
HHSBB01

  • Non-adherent bed sheet
One time use non-sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 2
Not in Commercial Distribution

  • 00857048006026 ()

  • Height: 0.85 Inch
  • Width: 3.35 Inch
  • Length: 8.0 Inch
HHTCK01

  • First aid kit, non-medicated, single-use
One time use sterile emergency airway kit that contains (1) Disposable Scalpel #10 blade, (1) Endotracheal Tube, 6.0 mm cuffed, (1) Curved Crile Hemostat, (1) News Tracheal Hook, (1) 10 cc syringe, (1) 35 cm Bougie and Twill Tape.
H&H MEDICAL CORPORATION
Version 5
In Commercial Distribution

  • 00857048006002 ()

  • Height: 1.75 Inch
  • Width: 4.0 Inch
  • Length: 9.25 Inch
HHECT01

  • Cricothyrotomy kit, single-use
Transurethral Suprapubic endo-Cystostomy
SWAN VALLEY MEDICAL, INCORPORATED
T14
In Commercial Distribution


  • Catheter Gauge: 18 French
114

  • Suprapubic drainage catheter
Transurethral Suprapubic endo-Cystostomy
SWAN VALLEY MEDICAL, INCORPORATED
T7
In Commercial Distribution


  • Catheter Gauge: 18 French
107

  • Suprapubic drainage catheter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL-M Black
In Commercial Distribution

  • 00856964007919 ()
M430N-MABK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500E Black
In Commercial Distribution

  • 00856964007780 ()
M430N-DLBK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500C Black
In Commercial Distribution

  • 00856964007728 ()
M430N-DCBK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Black
In Commercial Distribution

  • 00856964007698 ()
M430N-AABK-CMZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500D Black
In Commercial Distribution

  • 00856964007094 ()
M430N-DLBK-JPZA

  • Pulse oximeter
Fingertip Pulse Oximeter
EINSTEIN ASSOCIATES LLC
500DL Black
In Commercial Distribution

  • 00856964007049 ()
M430N-AABK-JPZA

  • Pulse oximeter
No Description
FUJIFILM NEW DEVELOPMENT U.S.A., INC.
Rev A
Not in Commercial Distribution

  • 00856853006009 ()
1001

  • Laparoscopic access cannula, single-use
The Tactical Medical Kit - Covert Trauma Pouch (TMK-CTP) was designed to be small enough for everyday or discreet carry while still capable of holding all supplies necessary for TCCC recommended treatment.
Altitude Technologies Inc.
01328BK-CAT
In Commercial Distribution

  • 00856767008984 ()
01328BK-CAT

  • First aid kit, non-medicated, single-use
The Tactical Medical Kit - Combat Lifesaver (TMK-CL) contains essential medical supplies to administer lifesaving care.
Altitude Technologies Inc.
01276BK
In Commercial Distribution

  • 00856767008939 ()
01276BK

  • First aid kit, non-medicated, single-use
Tactical Medical Kit - Care Under Fire, Advanced, Black, CAT
Altitude Technologies Inc.
01349BK-CAT
In Commercial Distribution

  • 00856767008380 ()
01349BK-CAT

  • First aid kit, non-medicated, single-use
Tactical Medical Kit - Care Under Fire, Advanced, Black, SOFTT-W
Altitude Technologies Inc.
01349BK
In Commercial Distribution

  • 00856767008373 ()
01349BK

  • First aid kit, non-medicated, single-use
Tactical Medical Kit - Massive Hemorrhage, Airway, Respirations, Circulation, Hypothermia Prevention, Black with CAT
Altitude Technologies Inc.
01437BK-CAT
In Commercial Distribution

  • 00856767008267 ()
01437BK-CAT

  • First aid kit, non-medicated, single-use
Tactical Medical Kit - Massive Hemorrhage, Airway, Respirations, Circulation, Hypothermia Prevention, Black with SOFTTW
Altitude Technologies Inc.
01437BK
In Commercial Distribution

  • 00856767008250 ()
01437BK

  • First aid kit, non-medicated, single-use
5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System. The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-017-005
In Commercial Distribution

  • 00856750007116 ()
PE-002-017-005

  • Cardiac electrophysiology analysis system
5 cables in one bag with single jumper cables black to split ECG signals between two ECG devices is an accessory to the PURE EP System. The PURE EP™ is a system that consists of two main parts: the amplifier (aka MSU - Main System Unit), and the personal computer (PC), which are connected over a highspeed fiber optic cable. The patient is connected to the amplifier via a set of supplied ECG cables and commercially available intracardiac (IC) catheters. The amplifier includes hardware and embedded software necessary for acquiring ECG and IC signals from patients. The device is not intended for active patient monitoring. It consists of one ECG and seven IC modules designed to acquire 12-lead ECG and 56 IC signals and send the digitized data to the PC. The PC has preinstalled PURE-EP software and is connected to display monitors. The pre-installed software provides visualization of received data from the amplifier on real-time and review screens. It also includes a signal processing module that provides various filter options for real-time and review screens.
BIOSIG TECHNOLOGIES, INC.
PE-002-014-005
In Commercial Distribution

  • 00856750007109 ()
PE-002-014-005

  • Cardiac electrophysiology analysis system
For supporting the vagina during laparoscopic vaginal procedures. 50 mm width, inserted end.
KRONNER PROTOTYPES, INCORPORATED
VCM-50
In Commercial Distribution

  • 00856589007059 ()


  • Vaginal retractor, self-retaining
For supporting the vagina during laparoscopic vaginal procedures. 45 mm width, inserted end.
KRONNER PROTOTYPES, INCORPORATED
VCM-45
In Commercial Distribution

  • 00856589007042 ()


  • Vaginal retractor, self-retaining
For supporting the vagina during laparoscopic vaginal procedures. 40 mm width, inserted end.
KRONNER PROTOTYPES, INCORPORATED
VCM-40
In Commercial Distribution

  • 00856589007035 ()


  • Vaginal retractor, self-retaining
TOTAL TRAY ADD-A-CATH W/URINE
MEDLINE INDUSTRIES, INC.
URO180200
In Commercial Distribution

  • 40889942839194 ()
  • 10889942839193 ()
URO180200

  • Indwelling urethral catheterization kit, adult
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