Question 1

INFUSION THERAPY

Answer

Safety Scalp Vein Set Scalp Vein Set Infusion Set IV Burette IV Cannula Safety IV Cannula IV Cannula Dressing Sterile IV Start Kit Extension Tube Three Way Stopcock

Question 2

SYRINGE AND NEEDLE

Answer

Disposable Syringe with Needle Disposable Syringe with Safety Needle Safety Syringe Safety Needle Disposable Hypodermic Needle Auto-Disable Syringes for Fixed-Dose Immunization Pre-Filled Flush Syringes Dental Needle Irrigation Needle Suture Removal Set Veterinary Needle Hard Pack Syringe

Question 3

HAZARDOUS DRUG SAFETY

Answer

Aspiration Needle with Safety Shield Blunt Needle With/Without Filter Curved Needle Side Hole Needle Needle Free System Safety Box for the Disposal of Used Sharps Sharp Container Endoscope Transport Pad Ultimate Sharps Safety Stations (Needle Counter) Safety Medical Products for Needle Stick Prevention

Question 4

NUTRITION THERAPY

Answer

Enfit® Syringe Enfit® Connector Enfit® Feeding Set Oral Syringe Irrigation Syringe

Question 5

SPECIMEN COLLECTION

Answer

Blood Collection Needle Safety Blood Collection Needle Safety Blood Lancet Blood Collection Tube

Question 6

ANESTHESIA & PAIN MANGMENT

Answer

Spinal Needle Anesthesia Kit High Pressure Manifold Nrfit™ Syringe

Question 7

TRANSFUSION THERAPY

Answer

Gravity Blood Administration Sets Blood Bag Cord Blood Bag Collection Set

Question 8

URINARY CARE

Answer

Urine Drainage Bag Leg Bag Urine Meter Irrigation Tray Irrigation Syringe

Question 9

DIABETES CARE

Answer

Safety Insulin Syringe Insulin Syringe Insulin Pen Needle Safety Insulin Pen Needle Sharp Disposal Container For Insulin Needle Alcohol Swab

Question 10

RENAL CARE

Answer

Fistula Needle Safety Fistula Needle Blood Line Hemodialysis Care Kit

ANESTHESIA & PAIN MANAGEMENT

PRODUCTS

INFUSION THERAPY

SYRINGE AND NEEDLE

HAZARDOUS DRUG SAFETY

NUTRITION THERAPY

SPECIMEN COLLECTION

ANESTHESIA & PAIN MANGMENT

TRANSFUSION THERAPY

URINARY CARE

DIABETES CARE

RENAL CARE

MAIN OFFICE

MAIN PRODUCTS

510K Number

INFUSION THERAPY

SYRINGE AND NEEDLE

HAZARDOUS DRUG SAFETY

NUTRITION THERAPY

SPECIMEN COLLECTION

ANESTHESIA & PAIN MANAGEMENT

TRANSFUSION THERAPY

URINARY CARE

DIABETES CARE

RENAL THERAPY

FDA K182649 (For ENFit Products)

FDA K192681 (For Blood Collection Devices)

FDA K192681 (For Scalp Vein Set)

FDA K210854 (Enteral Feeding Set)

FDA K211329 (Syringe and Needle)

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