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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 Clearview® COMPLETE HIV 1/2 assay is a single-use immunochromatographic test for the detection of antibodies to Human Immunodeficiency Virus Types 1 (HIV-1) and Type 2 (HIV-2) in fingerstick whole blood, venous whole blood, and serum or plasma specimens. The Clearview® COMPLETE HIV 1/2 assay is intended for use as a point-of-care test to aid in the diagnosis of infection with HIV-1 and HIV-2. This test is suitable for use in multi-test algorithms designed for the statistical validation of rapid HIV test results. When multiple rapid HIV tests are available, this test should be used in appropriate multi-test algorithms. Each kit contains 25 individually pouched tests, 25 Disposable Test Stands, 1 Product Insert, and 25 Copies of Subject Information Notice.
Chembio Diagnostic Systems Inc.
60-9523-0
Not in Commercial Distribution

  • 00607158000021 ()


  • HIV1/HIV2 antibody IVD, kit, immunochromatographic test (ICT), rapid, professional/self-test
The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex.
Dale Medical Products, Inc.
475
In Commercial Distribution

  • H84104751 ()
  • H84104752 ()
475

  • Enteral feeding kit, adult/paediatric, sterile
The Dale ACE Connector is a plastic universal connector that provides in-line feeding, suctioning, irrigation and medication delivery while reducing the risk of potentially infectious splash back. The connector controls fluid flow into and out of most NG feeding tubes and other enteral tubes. The connector remains closed to the atmosphere, reducing the risk of cross contamination and eliminates mess and formula loss by maintaining a closed system (no disconnect). It has a simple ON/OFF handle and built in Needleless Syringe Port Seal which accepts most catheter tip 60 ml syringes. It is designed to physically prevent the administration of enteral formula into an I.V. line and is incompatible with luer connectors. The ACE Connector is DEHP free and not made with natural rubber latex.
Dale Medical Products, Inc.
475
In Commercial Distribution

  • H84104751 ()
  • 00817612020254 ()
  • 00817612020247 ()
475

  • Enteral feeding kit, adult/paediatric, sterile
Bi-directional oxygenator gas line filter for use in gas lines and is indicated for the removal of bacteria, scale and other contaminants from oxygen and other medical gases.
Pall International Sàrl
ORO1H
In Commercial Distribution

  • 35034480000447 ()
  • 05034480000446 ()

  • >99.999% airborne bacterial removal efficiency
ORO1H

  • Microbial medical gas filter, sterile, single-use
ChekMate™ Strips are dry strips that mimic the use of the PTS Panels test strips to check the CardioChek analyzer system optics, calibration, and result handling algorithms.
POLYMER TECHNOLOGY SYSTEMS, INC.
860
Not in Commercial Distribution

  • 00381930860019 ()
  • 10381930860016 ()
860

  • Glucose/ketone/lipid profile IVD, calibrator
MILLER Laryngoscope blade fig 00, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (44 mm) (pack of 10)
Carnegie Surgical LLC
404-7697
In Commercial Distribution

  • G14140476971 ()
  • G14140476970 ()
  • G14140476972 ()
404-7697

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 4, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (182 mm) (pack of 10)
Carnegie Surgical LLC
404-7648
In Commercial Distribution

  • G14140476481 ()
  • G14140476480 ()
  • G14140476482 ()
404-7648

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 3, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (175 mm) (pack of 10)
Carnegie Surgical LLC
404-7638
In Commercial Distribution

  • G14140476381 ()
  • G14140476380 ()
  • G14140476382 ()
404-7638

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 2, conventional with LED and medium plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (134 mm) (pack of 10)
Carnegie Surgical LLC
404-7628
In Commercial Distribution

  • G14140476281 ()
  • G14140476280 ()
  • G14140476282 ()
404-7628

  • Rigid intubation laryngoscope, single-use
MILLER Laryngoscope blade fig 2, conventional with LED and small plastic handle combination, battery included, single patient use, non-sterile, metal flap, working length (134 mm) (pack of 10)
Carnegie Surgical LLC
404-7627
In Commercial Distribution

  • G14140476271 ()
  • G14140476270 ()
  • G14140476272 ()
404-7627

  • Rigid intubation laryngoscope, single-use
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