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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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Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 3.8 IN x 4.6 IN, 100 Dressings/Case, 1492CH
ENTROTECH LIFE SCIENCES, LLC
1492BOX
In Commercial Distribution

  • B5591492CASE3 ()
  • B5591492BOX1 ()
  • B5591492CH0 ()
1492BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, I.V. Securement, 2.8 IN x 3.5 IN, 100 Dressings/Case, 1491CH
ENTROTECH LIFE SCIENCES, LLC
1491BOX
In Commercial Distribution

  • B5591491CH0 ()
  • B5591491BOX1 ()
  • B5591491CASE3 ()
1491BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressing
ENTROTECH LIFE SCIENCES, LLC
1485CH
In Commercial Distribution

  • B5591485CH00 ()
1485CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 4 IN x 4.75 IN, 200 Dressings/Case, 1485CH
ENTROTECH LIFE SCIENCES, LLC
1485BOX
In Commercial Distribution

  • B5591485BOX1 ()
  • B5591485CH0 ()
  • B5591485CASE3 ()
1485BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressing
ENTROTECH LIFE SCIENCES, LLC
1484CH
In Commercial Distribution

  • B5591484CH00 ()
1484CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 2.375 IN x 2.75 IN, 400 Dressings/Case, 1484CH
ENTROTECH LIFE SCIENCES, LLC
1484BOX
In Commercial Distribution

  • B5591484BOX1 ()
  • B5591484CH0 ()
  • B5591484CASE3 ()
1484BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressing
ENTROTECH LIFE SCIENCES, LLC
1483CH
In Commercial Distribution

  • B5591483CH00 ()
1483CH

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
Prevahex Antimicrobial Transparent Film Dressings, Frame Style, 1.75 IN x 1.75 IN, 400 Dressings/Case, 1483CH
ENTROTECH LIFE SCIENCES, LLC
1483BOX
In Commercial Distribution

  • B5591483BOX1 ()
  • B5591483CH0 ()
  • B5591483CASE3 ()
1483BOX

  • Antimicrobial synthetic polymer semi-permeable film dressing, adhesive
ClearGuard HD end caps are blood access device accessories. The ClearGuard Hemodialysis (HD) end cap is a male luer lock end cap with the antimicrobial agent chlorhexidine acetate on the rod and lock ring threads. Each package contains two ClearGuard HD end caps assembled in a shield. The total amount of chlorhexidine acetate on a pair of devices is not more than 2.4 mg, and the maximum amount that is available to be released to the patient is 0.6 mg per device pair. The ClearGuard HD end caps can be used for up to a maximum of 72 hours. ClearGuard HD is indicated for use as an end cap for use with hemodialysis catheter hubs. The antimicrobial treatment on the ClearGuard HD end cap has been shown to be effective at reducing microbial colonization in hemodialysis catheter hubs against the following microorganisms: Enterococcus faecium (VRE), Enterococcus faecalis (VRE), Acinetobacter baumannii, Escherichia coli, Staphylococcus aureus (MRSA), Staphylococcus aureus, Staphylococcus epidermidis (MRSE), Pseudomonas aeruginosa, Candida albicans and Candida parapsilosis and has not been shown to be effective against Candida paratropicalis and Klebsiella pneumoniae. The antimicrobial effectiveness was evaluated using in vitro methods, and correlation between in vitro antibacterial activity and any clinical effectiveness has not been tested. The subject device is not intended to be used for the treatment of existing infections. The antimicrobial is only effective within the hub of the catheter and does not migrate to distal portions of the catheter.
Pursuit Vascular, Inc.
CGHD
Not in Commercial Distribution

  • B081CGHD107258070 ()


  • Luer-formatted disinfection cap
NEEDLE,30 X 1/2
American Health Service Sales Corporation
AHS3013RN
In Commercial Distribution

  • B031AHS3013RN2 ()
  • B031AHS3013RN1 ()
  • B031AHS3013RN0 ()


  • Hypodermic needle, single-use
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