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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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Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
Sugentech Inc._Osong Branch
Surearly SMART (SSMD001E)
In Commercial Distribution

  • 08809408863499 ()


  • Immunoassay reagent vehicle reader IVD
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2"(12.7mm), U-100, 100/bx, 20bx/cs
In Commercial Distribution

  • 00810008215951 ()
  • 00810008215944 ()
  • 00810008215968 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 27 Gauge
  • Length: 12.7 Millimeter
2259

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2"(12.7mm), U-100, 100/bx, 20bx/cs
In Commercial Distribution

  • 00810008215920 ()
  • 00810008215913 ()
  • 00810008215937 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 12.7 Millimeter
2256

  • Insulin syringe/needle, basic
1 Pre-Filled Normal Saline Flush Syringe 10 cc(sterilized)(China) 1 Extension set(sterilized)(China) 1 Alcohol prep pad(sterilized)(China) 1 Patient label(Non-sterile)(China) 1 Gauze, 2'' x 2''x2, 4 ply(sterilized)(China) 1 Mini roll of tape(Non-sterile)(China) 1 Tegaderm, 6 cm x 10 cm(sterilized)(China) 1 Tourniquet 1'' x 18'', Blue, Rolled(Non-sterile)(China)
AMSINO INTERNATIONAL, INC.
1
In Commercial Distribution

  • 40704411017838 ()
  • 10704411017837 ()
IVSK005

  • Peripheral intravenous catheterization kit, non-sensing
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 0.3ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10,100/bx
In Commercial Distribution

  • 00810008216477 ()
  • 00810008216484 ()
  • 00810008216989 ()

  • Needle Gauge: 31 Gauge
  • Total Volume: 0.3 Milliliter
  • Length: 8 Millimeter
2241

  • Insulin syringe/needle, basic
Porcelain Repair Kit (Clear) includes 1 (2.5 cc) PorcelETCH™ Clear, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661015
In Commercial Distribution

  • D7796610153 ()
661015

  • Dental repair kit, ceramic
Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661005
In Commercial Distribution

  • D7796610053 ()
661005

  • Dental repair kit, ceramic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/bx,
In Commercial Distribution

  • 00810008215890 ()
  • 00810008215883 ()
  • 00810008215906 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 8 Millimeter
2255

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 1ml/cc, 31g x 5/16"(8mm), U-100, 10/bg x 10, 100/bx,
In Commercial Distribution

  • 00810008215869 ()
  • 00810008215852 ()
  • 00810008215876 ()

  • Total Volume: 1 Milliliter
  • Needle Gauge: 31 Gauge
  • Length: 8 Millimeter
2254

  • Insulin syringe/needle, basic
The GLUCO-CARE insulin syringe is a sterile, single-use medical device designed for the subcutaneous administration of insulin. It consists of a transparent barrel with graduated measurement markings, a fixed or detachable needle, and a plunger for precise insulin delivery. The syringe is available in multiple capacities (e.g., 0.3 mL, 0.5 mL, and 1.0 mL) with varying needle lengths and gauges to accommodate different patient needs.
MediVena, LLC
GLUCO-CARE Insulin Syringes 0.5ml/cc, 30G x 5/16"(8mm), U-100, 10/bg x 10, 100/b
In Commercial Distribution

  • 00810008215838 ()
  • 00810008215821 ()
  • 00810008217009 ()

  • Total Volume: 0.5 Milliliter
  • Needle Gauge: 30 Gauge
  • Length: 8 Millimeter
2248

  • Insulin syringe/needle, basic
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