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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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Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A6
In Commercial Distribution

  • B268Y7078A61 ()
  • B268Y7078A60 ()
  • B268Y7078A64 ()
  • B268Y7078A69 ()


  • General-purpose patient temperature probe, reusable
American Red Cross Multi-Use Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078
In Commercial Distribution

  • B268Y707894 ()
  • B268Y70784 ()
  • B268Y70781 ()
  • B268Y70780 ()


  • General-purpose patient temperature probe, reusable
American Red Cross Baby Healthcare Kit
TOMY INTERNATIONAL, INC.
Y7054
In Commercial Distribution

  • B268Y70549 ()
  • B268Y70544 ()
  • B268Y70541 ()
  • B268Y7054Y705701 ()
Y7054

  • Infant care kit
Y7057 American Red Cross Healthcare & Grooming Kit (with Thermometer)
TOMY INTERNATIONAL, INC.
Y7054, Y7057
In Commercial Distribution

  • B268Y7054Y70579 ()
  • B268Y7054Y70573 ()
  • B268Y7054Y70571 ()
  • B268Y7054Y70570 ()
Y7057

  • Infant care kit
TFY Rapid Read Underarm Thermometer
TOMY INTERNATIONAL, INC.
Y7051
In Commercial Distribution

  • B268Y70514 ()
  • B268Y70516 ()
  • B268Y70511 ()
  • B268Y70510 ()


  • General-purpose patient temperature probe, reusable
Teether
TOMY INTERNATIONAL, INC.
Y5228L
In Commercial Distribution

  • B268Y5288L9 ()
  • B268Y5288L6 ()
  • B268Y5288L1 ()
  • B268Y5288L0 ()


  • Teething device, fluid-filled
Star Teether
TOMY INTERNATIONAL, INC.
Y5288
In Commercial Distribution

  • B268Y52880 ()
  • B268Y52281 ()
  • B268Y52886 ()
  • B268Y52889 ()


  • Teething device, fluid-filled
Water Filled Chill Teethers
TOMY INTERNATIONAL, INC.
L27619
In Commercial Distribution

  • B268L276198 ()
  • B268L276192 ()
  • B268L276190 ()
  • B268L276199 ()
L27619

  • Teething device, fluid-filled
LAMAZE JD Chill Teether
TOMY INTERNATIONAL, INC.
L27412
In Commercial Distribution

  • B268L274120 ()
  • B268L274122 ()
  • B268L274128 ()
  • B268L274129 ()
L27412

  • Teething device, fluid-filled
BOON Care Health Kit (Thermometer)
TOMY INTERNATIONAL, INC.
B11185
In Commercial Distribution

  • B268B111859 ()
  • B268B111854 ()
  • B268B111851 ()
  • B268B111850 ()


  • Infant care kit
Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7957
In Commercial Distribution

  • B268Y79571 ()
  • B26879570 ()
  • B268Y79573 ()
  • B268Y79579 ()
Y7957

  • Infant care kit
Polyp Trap with screw top, fine-mesh screen and tube with connector.. Package of 10.
M D Technologies Inc.
PT20C-10
In Commercial Distribution

  • B325PT20C100 ()
  • B325PT20C101 ()
  • B325PT20C252 ()
  • B325PT20C503 ()
  • B325PT20C1004 ()
PT20C10

  • Surgical suction system collection container, single-use
Polyp Trap with screw top, fine-mesh screen and plain tube. Package of 10.
M D Technologies Inc.
PT20-10
In Commercial Distribution

  • B325PT20252 ()
  • B325PT20100 ()
  • B325PT20503 ()
  • B325PT201004 ()
  • B325PT20101 ()
PT2010

  • Surgical suction system collection container, single-use
LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

  • B311PEPADBFLY1 ()
  • B311PEPADBFLY0 ()
  • B311PEPADBFLY2 ()
  • B311PEPADBFLY3 ()


  • Transcutaneous electrical stimulation electrode, single-use
Intended for use in the qualitative detection of oral, rectal and genitourethral Neisseria gonorrhoeae colonization.
BIO-MED DIAGNOSTICS, INC.
1080
In Commercial Distribution

  • B08810804 ()
  • B08810800 ()
  • B08810802 ()
  • B08810803 ()
10-8000

  • Neisseria gonorrhoeae culture isolate identification IVD, kit
Flo2Max 5-in-1 Oxygen Mask, Child
B.L.S. Systems Limited
6110
In Commercial Distribution

  • B00266107 ()
  • B00261100 ()
  • B00261109 ()
  • B00261107 ()

  • Child
6110

  • Non-rebreathing oxygen face mask
S-CRYOLOCK - YELLOW - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (Y)
In Commercial Distribution

  • B056SCLY5 ()
  • B056SCLY2 ()
  • B056SCLY1 ()
  • B056SCLY0 ()
  • B056SCLY3 ()
S-CL (YELLOW)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - ORANGE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (O)
In Commercial Distribution

  • B056SCLO5 ()
  • B056SCLO2 ()
  • B056SCLO1 ()
  • B056SCLO0 ()
  • B056SCLO3 ()
S-CL (ORANGE)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - GREEN - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (G)
In Commercial Distribution

  • B056SCLG5 ()
  • B056SCLG2 ()
  • B056SCLG1 ()
  • B056SCLG0 ()
  • B056SCLG3 ()
S-CL (GREEN)

  • Assisted reproduction vitrification carrier
S-CRYOLOCK - CLEAR - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (C)
In Commercial Distribution

  • B056SCLC5 ()
  • B056SCLC2 ()
  • B056SCLC1 ()
  • B056SCLC0 ()
  • B056SCLC3 ()
S-CL (CLEAR)

  • Assisted reproduction vitrification carrier
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