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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 First Years - B268Y7078A60

Digital Thermometer
TOMY INTERNATIONAL, INC.
Y7078A6
In Commercial Distribution

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


  • General-purpose patient temperature probe, reusable

American Red Cross - B268Y70780

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 - B268Y7054Y705701

American Red Cross Baby Healthcare Kit
TOMY INTERNATIONAL, INC.
Y7054
In Commercial Distribution

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

  • Infant care kit

American Red Cross - B268Y7054Y70570

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

The First Years - B268Y70510

TFY Rapid Read Underarm Thermometer
TOMY INTERNATIONAL, INC.
Y7051
In Commercial Distribution

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


  • General-purpose patient temperature probe, reusable

Lamaze - B268Y5288L0

Teether
TOMY INTERNATIONAL, INC.
Y5228L
In Commercial Distribution

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


  • Teething device, fluid-filled

The First Years - B268Y52880

Star Teether
TOMY INTERNATIONAL, INC.
Y5288
In Commercial Distribution

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


  • Teething device, fluid-filled

Lamaze - B268L276190

Water Filled Chill Teethers
TOMY INTERNATIONAL, INC.
L27619
In Commercial Distribution

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

  • Teething device, fluid-filled

LAMAZE/JOHN DEERE - B268L274120

LAMAZE JD Chill Teether
TOMY INTERNATIONAL, INC.
L27412
In Commercial Distribution

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

  • Teething device, fluid-filled

BOON - B268B111850

BOON Care Health Kit (Thermometer)
TOMY INTERNATIONAL, INC.
B11185
In Commercial Distribution

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


  • Infant care kit

The First Years - B26879570

Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7957
In Commercial Distribution

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

  • Infant care kit

Environ-mate - B325PT20C101

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

Environ-mate - B325PT20101

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

PURE ENRICHMENT - B311PEPADBFLY0

LARGE ELECTRODE PAD
BEAR DOWN CONSULTING
PEPADBFLY
In Commercial Distribution

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


  • Transcutaneous electrical stimulation electrode, single-use

InTray™ GC - B08810800

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 Oxygen Mask, Child - B00261100

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 (Y) - B056SCLY1

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 (O) - B056SCLO1

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 (G) - B056SCLG1

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 (C) - B056SCLC1

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

S-CRYOLOCK (B) - B056SCLB1

S-CRYOLOCK - BLUE - Cryopreservation storage device that is intended for use in vitrification procedures to contain and maintain human 1-cell stage embryos
BIOTECH INCORPORATED
S-CL (B)
In Commercial Distribution

  • B056SCLB5 ()
  • B056SCLB2 ()
  • B056SCLB1 ()
  • B056SCLB0 ()
  • B056SCLB3 ()
S-CL (BLUE)

  • Assisted reproduction vitrification carrier

Molded Products, Inc. - B144MPC124R0

Luer Lock Cap - Red
MOLDED PRODUCTS, INC.
MPC-124R
In Commercial Distribution

  • B144MPC124R1 ()
  • B144MPC124R0 ()
  • B144MPC124R2 ()
  • B144MPC124R3 ()
MPC-124R

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC124B0

Luer Lock Cap
MOLDED PRODUCTS, INC.
MPC-124-B
In Commercial Distribution

  • B144MPC124B3 ()
  • B144MPC124B2 ()
  • B144MPC124B1 ()
  • B144MPC124B0 ()
MPC-124-B

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1150

Female Luer Lock - White - Replacement Cap
MOLDED PRODUCTS, INC.
MPC-115
In Commercial Distribution

  • B144MPC1153 ()
  • B144MPC1152 ()
  • B144MPC1151 ()
  • B144MPC1150 ()
MPC-115

  • Luer-formatted disinfection cap

Molded Products, Inc - B144MPC100S0

Latex-Free Access Site with Luer Slip
MOLDED PRODUCTS, INC.
MPC-100-S
In Commercial Distribution

  • B144MPC100S1 ()
  • B144MPC100S0 ()
  • B144MPC100S2 ()
  • B144MPC100S3 ()
MPC-100-S

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1000

Intermittent Injection Cap
MOLDED PRODUCTS, INC.
MPC-100
In Commercial Distribution

  • B144MPC1003 ()
  • B144MPC1002 ()
  • B144MPC1001 ()
  • B144MPC1000 ()
MPC-100

  • Catheter injection port

Molded Products, Inc. - B144MPC7450

Collection Assist Device that collects a clean sample from the female hansen port of a hemodialysis machine.
MOLDED PRODUCTS, INC.
MPC-745
In Commercial Distribution

  • B144MPC7451 ()
  • B144MPC7450 ()
  • B144MPC7452 ()
  • B144MPC7453 ()
MPC-745

  • Haemodialysis treatment kit

Molded Products, Inc. - B144MPC1250

Luer Lock Cap Set - (1) Red and (1) Blue per set
MOLDED PRODUCTS, INC.
MPC-125
In Commercial Distribution

  • B144MPC1251 ()
  • B144MPC1250 ()
  • B144MPC1252 ()
  • B144MPC1254 ()
MPC-125

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC1230

Dual End Cap - Male/Female
MOLDED PRODUCTS, INC.
MPC-123
In Commercial Distribution

  • B144MPC1231 ()
  • B144MPC1230 ()
  • B144MPC1232 ()
  • B144MPC1233 ()
MPC-123

  • Luer-formatted disinfection cap

Molded Products, Inc. - B144MPC115LB500

Female Luer Lock Cap - Lt. Blue, 50 pcs per bag
MOLDED PRODUCTS, INC.
MPC-115LB-50
In Commercial Distribution

  • B144MPC115LB503 ()
  • B144MPC115LB502 ()
  • B144MPC115LB501 ()
  • B144MPC115LB500 ()
  • B144MPC115LB0 ()
MPC-115LB-50

  • Luer-formatted disinfection cap
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