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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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Integra® Pudenz Peritoneal Catheter Pudenz Peritoneal Catheter
Integra Lifesciences Corporation
NL8501380
In Commercial Distribution

  • 10381780072317 ()
  • M269NL85013801 ()

  • Tubing: 1.3mm ID x 2.5mm OD; Total Length: 90 cm (35 1/2") (All dimensions nominal)
NL8501380

  • Peritoneal/atrial cerebrospinal fluid catheter
The Accelerate PhenoTest® BC kit is a multiplexed in vitro diagnostic test utilizing both qualitative nucleic acid fluorescence in situ hybridization (FISH) identification (ID/AST configuration) and quantitative, antimicrobial susceptibility testing (AST) methods (ID/AST and AST configurations) and is intended for use with the Accelerate Pheno® system. The Accelerate PhenoTest® BC kit is capable of simultaneous detection and identification of multiple microbial targets (ID/AST configuration) followed by susceptibility testing of the appropriate detected bacterial organisms (ID/AST and AST configuration). The Accelerate PhenoTest® BC kit is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results.
ACCELERATE DIAGNOSTICS, INC.
10104018
In Commercial Distribution

  • 00862011000383 ()


  • Multiple-type bloodstream pathogen nucleic acid IVD, kit, nucleic acid amplification/mass spectrometry
Uni-Lim 60" Anesthesia Breathing Circuit, w/Cap, 10' x .060" ID M/M GSL, Medium Adult Mask 900 Series, 3L Not made with latex bag, B/V Filter
WESTMED, INC.
9106
In Commercial Distribution

  • 00709078009396 ()
  • 10709078009393 ()


  • Anaesthesia breathing circuit, single-use
Uni-Lim 72" Adult Anesthesia Breathing Circuit, Elbow ISL 10' x .060" ID Female, 3L Not made with Latex breathing bag, B/V filter, Series 700 large adult mask
WESTMED, INC.
8989
In Commercial Distribution

  • 10709078009324 ()
  • 00709078009327 ()


  • Anaesthesia breathing circuit, single-use
Uni-Lim 40" Anesthesia Breathing Circuit GSE Clear, 10' x .050 ID M/M GSL, Medium Adult Mask Series 900, #L not made with latex bag, B/V Filter
WESTMED, INC.
8004
Not in Commercial Distribution

  • 00709078009006 ()
  • 10709078009003 ()


  • Anaesthesia breathing circuit, single-use
Gas Sampling Line .047" ID x 96" length P/PV with Male/Female Luer Lock Connectors, 5.0um Hydrophobic Filter, PTFE, 25 mm Obsoleted 12-15-2019, marketing sku reduction project.
SALTER LABS
ZML-9441-1
Not in Commercial Distribution

  • 10607411940610 ()
  • 00690741194061 ()
ZML-9441-1

  • Nasal oxygen cannula, carbon-dioxide-sampling
72" Pediatric Corrugate Anesthesia Circuit, GSE, Parallel WYE, HMEF, B/V Filter, Pediatric Mask, 1L Not made with Latex Breathing Bag, 10' x .060" ID M/M GSL
WESTMED, INC.
9394
In Commercial Distribution

  • 10709078014557 ()
  • 00709078014550 ()


  • Anaesthesia breathing circuit, single-use
  • Heat/moisture exchanger/microbial medical gas filter
Anesthesia Circuit, Adult, 96" Expandable, GSE w/CAP, Bifurcated WYE, GSL 10' x .050" ID M/M, 3L not made with latex breathing bag 2 B/V Filters
WESTMED, INC.
8632
In Commercial Distribution

  • 10709078010863 ()
  • 00709078010866 ()


  • Anaesthesia breathing circuit, single-use
Anesthesia Circuit, adult, 72" Expandable, GSE w/Port, Parallel WYE w/GSP, B/V Filter, 3L not made with latex breathing bag, 10' x .050 ID M/M
WESTMED, INC.
8234
In Commercial Distribution

  • 10709078010733 ()
  • 00709078010736 ()


  • Anaesthesia breathing circuit, single-use
Docent Disposable Neuro Monitoring Probe 3mm x 214mm electrode; 50mm wire with DIN42802 connector; OD 3.8mm x ID 3mm x 190mm sheath; 2m extension cable with DIN42802 connector
Technomed Engineering B.V.
4014-00
Not in Commercial Distribution

  • 08718375865347 ()
  • 08718375865293 ()


  • Nerve-locating system probe, single-use
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