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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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Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 9 months at 5°C.
Temptime Corporation
F9
In Commercial Distribution

  • 00852282007020 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 182 days at 5°C.
Temptime Corporation
F6
In Commercial Distribution

  • 00852282007013 ()


  • Medical product temperature point indicator, thermochemical
Time-Temperature Indicators for healthcare providers to distinguish between medical devices that have or have not been exposed to a specific time/temp profile with endpoint at 91 days at 5°C.
Temptime Corporation
F3
In Commercial Distribution

  • 00852282007006 ()


  • Medical product temperature point indicator, thermochemical
A 1-way 60 drops with 60" tube Adset connected to a 3cc transducer. The Safedraw is assembled with a 5cc restricted syringe stops at 2cc, with a 12" Pressure Tubing from the patient and a 48" Pressure tubing to the syringe. It also includes a separately packed 2x male protective caps and a Label Set.
ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.
682142
In Commercial Distribution

  • 50886333621427 ()
  • 00886333621422 ()

  • 3cc transducer, 60 drops Adset and 5cc syringe stops at 2cc
682142

  • Invasive-pressure external transducer, single-use
Liquid Urine Control Dipstick - Negative/Positive. Contains 2 vials Negative and 2 vials Positive. 8 week open vial stability at room temperature. 18 month open vial stability when stored at 2-8° C.
ALTA DIAGNOSTICS INC
303-12
In Commercial Distribution

  • 30858512007052 ()

  • Total Volume: 30 Milliliter
303-12

  • Multiple urine analyte IVD, control
Silicone-Based Personal Lubricant
CC Wellness LLC
72224
In Commercial Distribution

  • 10796494002978 ()
  • 00796494002971 ()


  • Sexual lubricant
Hybrid Personal Lubricant
CC Wellness LLC
72222
In Commercial Distribution

  • 10796494002961 ()
  • 00796494002964 ()


  • Sexual lubricant
Water-based Personal Lubricant
CC Wellness LLC
72221
In Commercial Distribution

  • 10796494002954 ()
  • 00796494002957 ()


  • Sexual lubricant
Proov PdG, Progesterone Metabolite Test. The only FDA-Cleared Test to Confirm Successful Ovulation at Home.
Mfb Fertility, Inc.
Confirm
In Commercial Distribution

  • 00860002790817 ()


  • Natural conception assistance kit
At home fertility test that measures all 4 cycle hormones for a comprehensive fertility map.
Mfb Fertility, Inc.
Pregnancy Pack
In Commercial Distribution

  • 00850035206126 ()


  • Natural conception assistance kit
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