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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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Welch Allyn, Inc. - 00732094319811

Surveyor S19 GEN2 Pat Monitoring System - Nellcor Sp02, ECG, Dual Temp, NIBP, IBP 1/2/3/4, CO2, starter kit, Cardiac Output, resistive color touchscreen 18.5" display w/ 1366 x 768 res AC or lithium ion rechargeable batt operation; US/CA pwr cord; AHA 5 wire ECG pat cable w/ clip ends; Edwards invasive blood pressure cable (qty 2) and Y cable; No cardiac output cable; Ext thermal printer(w/ starter pack of thermal paper roll, 1.97 in. x 100 ft.(50mm x 30.48m) 10 rolls); LAN; No mounting options
WELCH ALLYN, INC.
901138
In Commercial Distribution

  • 00732094319811 ()
SUR19-ZAC-DXAAX

  • General-purpose multi-parameter bedside monitor

CueSee® VeriSTAT LVM - 08718734961468

CueSee® VeriSTAT LVM is an assayed aqueous blood gas, electrolyte and metabolite control material suitable for calibration verification of the Abbott i -STAT® POCT analyzer. It is intended that CueSee® VeriSTAT LVM should be used in the periodic verification of the precision and accuracy of the Abbott i -STAT POCT analyzer when measuring: pH, pO2, pCO2, Na+, K+, Ca++, Cl -, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. A box of CueSee® VeriSTAT LVM contains 5 levels of control material: CueSee® VeriSTAT LVM Level 1 - 08718734961413 CueSee® VeriSTAT LVM Level 2 - 08718734961420 CueSee® VeriSTAT LVM Level 3 - 08718734961437 CueSee® VeriSTAT LVM Level 4 - 08718734961444 CueSee® VeriSTAT LVM Level 5 - 08718734961451
Eurotrol B.V.
220.000.005
In Commercial Distribution

  • 08718734961468 ()


  • Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Green Guard Trauma Kit - 00347682119553

8213 -1.000 EACH Blood Pressure Unit Adult w/ca 8215 -1.000 EACH Labtron Stethoscope 3015 -1.000 EACH GG Alcohol Swabs (50) 6102 -1.000 EACH 2" RIP-N-WRAP 6520 - 2.000 EACH Emergency Large Wound Dressing 3302 -4.000 EACH GG Cold Pack Medium/Boxed + 6400 -2.000 EACH GG Triangular Bandage + 8200 -1.000 EACH 5 1/2" Band Scissors 8202 -1.000 EACH Paramedic Scissors 6253- 2.000 EACH Waterproof Tape 1/2" x 5yds 6254 -2.000 EACH Waterproof Tape 1"x5 yds 8060 -1.000 EACH CPR Microshield 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 4106 -2.000 EACH GG 8oz Eye Wash 6314 1.000 EACH GG 1x3 Plastic Strip Bandage (60) 6115- 2.000 EACH 2" Sterile Gauze Roll 8053 -1.000 EACH Disposable Airway Assorted Sizes 1193 -1.000 EACH Trauma Kit Hard Pack (Empty) 8524 -1.000 EACH Space Blanket + 7920 -2.000 EACH Glove Wipes 6117 -2.000 EACH 3" Sterile Gauze Roll SS110 - 1.000 EACH MCR Stratos Black/Clear 8212I- 2.000 EACH Penlight Disposable - Ind.
Greenguard
1195
In Commercial Distribution

  • 50347682119558 ()
  • 00347682119553 ()
1195

  • First aid kit, medicated

MobiLab Standard Sexual Health Self Rapid Test - 00860008737304

The MobiLab Standard Sexual Health Self Screening Kit (urine specimen) includes individual test cassettes for: 1. Trichomonas Vaginalis (TV) 2. Candida Albicans (Yeast) (CA) 3. Gardnerella Vaginalis (GV) 4. Mycoplasma Genitalium (MG) 5. Chlamydia Trachomatis (CHT) 6. Neisseria Gonorrhoeae (NGH). Each test strip in the cassette is suitable for urine specimen tests. During testing, if a specific antigen presented in the urine specimen reacts with each test cassette in the T reagent area, the conjugate antigens complex will be bound with the test cassette’s antibody coated on the membrane in case of a positive result. This would show in a dark red colored line in the T line region of a positive result. In case of negative result, no conjugate would bind at the test cassette’s antibody in the T line region and no line would form in the T line region of the test membrane. The C line serves as an internal qualitative control of the test system to indicate that an adequate volume of specimen has been applied and the flow occurred. Absence of C line indicates an invalid test result.
MobiLab Medical Innovatives Inc.
MSSH
Not in Commercial Distribution

  • 00860008737304 ()


  • Sexually transmitted infection (STI) testing specimen collection kit IVD, home-use

Green Guard Deluxe Trauma Kit - 00347682011963

6115 -3.000 EACH 2" Sterile Gauze Roll 6117 -3.000 EACH 3" Sterile Gauze Roll 6400 -3.000 EACH GG Triangular Bandage + 6213 -4.000 EACH 5x9 Combine Dressing ABD 3302 -4.000 EACH GG Cold Pack Medium/Boxed + 6254 -2.000 EACH Waterproof Tape 1"x5 yds 6253 -2.000 EACH Waterproof Tape 1/2" x 5yds 8060 -1.000 EACH CPR Microshield 3015 -2.000 EACH GG Alcohol Swabs (50) 8053 -1.000 EACH Disposable Airway Assorted Siz 6397 -1.000 EACH GG Butterfly Bndg (10) 6603 -1.000 EACH Cotton Tip Appl 3" 100/Vial+ 4105 -1.000 EACH GG 4oz Eye Wash 4106 -1.000 EACH GG 8oz Eye Wash 6102 -1.000 EACH 2" RIP-N-WRAP 6103 -1.000 EACH 3" RIP-N-WRAP 3101 -1.000 EACH GG Tri-Antibiotic Ointment (25) 6300 -1.000 EACH GG 7/8x3 Fabric Strip Bandage (50) 6314 -1.000 EACH GG 1x3 Plastic Strip Bandage (60) 6206 -1.000 EACH GG 3x3 Gauze Pads (25) 6202 -1.000 EACH GG 2x2 Gauze Pads (25) 8215 -1.000 EACH Labtron Stethoscope 8213 -1.000 EACH Blood Pressure Unit Adult w/ca 7920 -2.000 EACH Glove Wipes 8202 -1.000 EACH Paramedic Scissors 8200 -1.000 EACH 5 1/2" Band Scissors 1193 -1.000 EACH Trauma Kit Hard Pack (Empty) 8524 -2.000 EACH Space Blanket +
Greenguard
1196
In Commercial Distribution

  • 50347682011968 ()
  • 00347682011963 ()
1196

  • First aid kit, medicated

BioButton Rechargeable Adhesives - 00850005949237

Adhesive accessory packs for wearable devices (OMI, ADB); ACCS-1-ST06-1-4
BIOINTELLISENSE, INC.
ACCS-1-ST06-1-4
In Commercial Distribution

  • 10850005949234 ()
  • 00850005949237 ()
  • 30850005949238 ()
  • 20850005949231 ()
  • 40850005949235 ()
N/A

  • Dressing-fixation skin adhesive tape, non-silicone

CTXA Hip Bone Mineral Densitometer - B052DICTXAHIP0

The CTXA Hip Bone Mineral Densitometer (CTXA Hip) is a software package intended for estimation of bone mineral content (BMC), in grams, and bone mineral density (BMD), in g/cm2, of the proximal femur. The CTXA Hip uses quantitative computed tomography (QCT) methods to derive bone mass and bone density estimates from 3D CT image data sets obtained from compatible, whole-body CT scanners and with compatible CT calibration phantoms. BMD estimates are derived in units of g/cm2 equivalent K2HPO4 density. The BMD estimates can be compared with CTCA Hip-derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data, and the T-scores ca be used by the physician an an aid in determining fracture risk. CTXA Hip uses the same technical procedures to acquire and calibrate CT image data as are used for the predicate device K894854: QCT Bone Mineral Density Analysis Software. CTXA Hip reference data for young normal US Caucasian females were acquired in a clinical study, so that patient results obtained using CTXA Hip can be compared to this normal reference population. The CTXA Hip BMD estimates compared to the CTXA Hip reference population are sued as an aid to the physician in identifying patients with low bone mineral density. Additionally, normal data comparisons provide a basis for estimating fracture risk. BMC and BMD estimates are returned by the CTXA Hip for the following proximal femur regions of interest (ROIs): (1) femoral neck, (2) trochanter, (3) intertrochanter, (4) Ward’s triangle, and (5) total hip (i.e., superposition of ROIs 1-3).
MINDWAYS SOFTWARE, INC.
K002113
In Commercial Distribution

  • B052DICTXAHIP0 ()
DI_CTXAHIP

  • CT system application software
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