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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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The SonACT Kit is an in vitro diagnostic reagent for use with the Sonoclot® Coagulation & Platelet Function Analyzer System. The SonACT test is a celite activated whole blood clotting time test. It may also be used with citrated whole blood and plasma. The SonACT Kit is intended for general purpose global hemostasis monitoring including: clot detection, fibrin formation, platelet function, and hyperfibrinolysis. The monitoring information is typically used for anticoagulant management up to high heparin levels (0 to approximately 6 units per ml), hypercoagulable and/or hypocoagulable screening, platelet function assessment, and hyperfibrinolysis screening. When used with the Sonoclot Analyzer System, the SonACT test provides quantitative Onset/ACT and Clot Rate results as well as qualitative and quantitative information on the Sonoclot Signature including: fibrin formation, platelet function, and hyperfibrinolysis. Each kit contains 24 lidded colorless plastic activation cuvettes, 24 probes, and instructions for use. The activation cuvettes contain a controlled amount of celite and a magnetic stir bar.
SIENCO, INC.
800-0431
In Commercial Distribution

  • B55880004310 ()
  • B55880004311 ()
800-0431

  • Multiple coagulation factor IVD, kit, clotting
Size: Standard 13 mm; Type: Radiopaque
Boston Medical Products, Inc.
42013R
In Commercial Distribution

  • EBES42013R0 ()
  • EBES42013R1 ()

  • Length (Outer Limb): 55 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 34 mm
  • Length (Upper Inner Limb): 24 mm
  • Length (Inner Limb): 69 mm
  • Outer Diameter (Inner Limb): 13 mm
42013R

  • Trachea prosthesis
Size: Standard 13 mm; Type: Clear
Boston Medical Products, Inc.
420013
In Commercial Distribution

  • EBES4200130 ()
  • EBES4200131 ()

  • Length (Outer Limb): 55 mm
  • Outer Diameter (Outer Limb): 11 mm
  • Length (Lower Inner Limb): 34 mm
  • Length (Upper Inner Limb): 24 mm
  • Length (Inner Limb): 69 mm
  • Outer Diameter (Inner Limb): 13 mm
420013

  • Trachea prosthesis
Size: 18 mm
Boston Medical Products, Inc.
450018
Not in Commercial Distribution

  • EBES4500180 ()
  • EBES4500181 ()

  • Length (Outer Limb): 76 mm
  • Outer Diameter (Outer Limb): 14 mm
  • Length (Lower Inner Limb): 39 mm
  • Length (Upper Inner Limb): 24 mm
  • Length (Inner Limb): 77 mm
  • Outer Diameter (Inner Limb): 18 mm
450018

  • Trachea prosthesis
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Key temp lock Door lock Data Logger Foot levelers Left hand hinge Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
SWC182464-LH-4B
In Commercial Distribution

  • B286SWC182464LH4B1 ()
SWC182464-LH-4B

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point Mobile base 3 Adjustable shelves Digital control Glass door Audible and visual over-temp alarm Left Hand Hinged Keyed temperature lock Door Lock Data Logger Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
SWC182464-G-LH-MB
In Commercial Distribution

  • B286SWC182464GLHMB1 ()
SWC182464-G-LH-MB

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Key temp lock Door lock Data Logger Foot levelers Recessed - w/sides and top Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
SWC182464-4B-R2
In Commercial Distribution

  • B286SWC1824644BR21 ()
SWC182464-4B-R2

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 64.75”T. 9.73 Cubic ft. storage Chamber I.D. 20”W x 17”D x 49.5”T. Temperature Range: 90-160 F Accuracy +/- 1 degrees F of set point 3 Adjustable shelves Digital control Stainless steel door Audible and visual over-temp alarm Key temp lock Door lock Data Logger Foot levelers Recessed - no sides or top Electrical: 120V, 7.5 Amp, 50/60 Hz .49kw/hr, 1678 btu/hr UL/CUL listed FDA Registered
M.A.C. MEDICAL INC.
SWC182464-4B-R1
In Commercial Distribution

  • B286SWC1824644BR11 ()
SWC182464-4B-R1

  • Blanket warming cabinet, dry-heat
Overall size 24”W x 20.5”D x 74.5”T. Upper Chamber I.D. 20”W x 17”D x 13.5”T 2.67 Cubic ft. storage. Lower chamber I.D. 20 “W x 17”D x 34.25”T 6.74 Cubic ft. storage. Digital control. Foot levelers. 3 Adjustable shelves. Stainless steel doors. Audible and visual over-temp alarm. Accuracy +/- 1 degrees F (upper chamber). Accuracy +/- 3 degrees F (lower chamber). Electrical: 120V, 15 Amp, 50/60 Hz. .75kw/hr, 2557 btu/hr
M.A.C. MEDICAL INC.
FHCDWC24-1824-TL
In Commercial Distribution

  • B286FHCDWC241824TL1 ()
FHCDWC24-1824-TL

  • Blanket warming cabinet, dry-heat
The Astute Medical NEPHROCHECK Test System is intended to be used in conjunction with clinical evaluation in patients who currently have or have had within the past 24 hours acute cardiovascular and or respiratory compromise and are ICU patients as an aid in the risk assessment for moderate or severe acute kidney injury (AKI) within 12 hours of patient assessment. The NEPHROCHECK Test System is intended to be used in patients 21 years of age or older.
BIOMERIEUX SA
500011
In Commercial Distribution

  • B0745000110 ()
500011

  • Multiple acute kidney injury (AKI) marker IVD, kit, fluorescent immunoassay
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