BEUDAMED
    Product Code: NGT FDA class 2 21 CFR 880.5200

    Saline, Vascular Access Flush

    General Hospital

    The Saline, Vascular Access Flush (product code NGT) is a general hospital device consisting of saline solution used to flush intravascular catheters to maintain patency and prevent clot formation, as described in its definition. It is classified as an FDA Class 2 device within the General Hospital specialty, requiring 510(k) premarket clearance. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.

    View on FDA
    510(k)s
    40
    FEI Numbers
    51
    Registration Numbers
    51
    Unique Applicants
    23
    Years Active
    24

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    Basic Information

    Product Code
    NGT
    Device Class
    FDA class 2
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Enhance the performance of intravascular catheters, to maintain patency of the vascular catheter when it is not in use.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 40 510(k) clearances via K numbers.

    K Number Device Name
    K250884 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe
    K233623 Praxiject™ SP 0.9% NaCl
    K231724 Flush Syringe (Prefilled 0.9% normal saline solution)
    K231363 Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)
    K230756 TK Pre-Filled Normal Saline Flush Syringe
    K223584 Pre-Filled Normal Saline Flush Syringe
    K231161 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe
    K231754 Praxiject™ 0.9% NaCl
    K214080 Pentaflush
    K213522 AMSafe Pre-Filled Normal Saline Flush Syringe
    K201286 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch
    K192414 Praxiject 0.9% NaCl
    K191378 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe
    K183473 AMSafe(R) Pre-Filled Normal Saline Flush Syringe
    K173348 0.9% Sodium Chloride Injection, USP
    K171109 Praxiject 0.9% NaCl
    K161552 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe
    K153481 0.9% Sodium Chloride Injection, USP BD PosiFlush SF Syringe
    K150143 Normal Saline Flush
    K142620 0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe
    K133685 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K141311 0.9% SODIUM CHLORIDE INJECTION, USP BD POSIFLUSH; SP SYRINGE, SF SYRINGE
    K121050 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE
    K121262 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY
    K121231 IND DRUG HOME MULTI-PANEL TEST (2-5) IND MORPHINE HOME TEST
    K120836 0.9% SODIUM CHLORIDE FLISH SYRINGE
    K113555 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K103740 SODIUM CHLORIDE INJECTION, 0.9%, USP 5 ML, 10 ML AMPULE
    K111034 AM USA 0.9% SODIUM CHLORIDE FLUSH SYRINGE
    K101270 SWABFLSUH (3ML, 5ML, 10ML) MODEL 10331, 10351, 10311
    K090882 FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
    K091583 MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE
    K082689 STERILE SODIUM CHLORIDE 0.9% FLUSH, 5ML, 10ML, AMPULE
    K082837 STERILE FIELD SALINE PRE-FILLED SYRINGE(S)
    K060339 KENDALL MONOJECT PRE-FILL ADVANCED 0.9%SODIUM CHLORIDE FLUSH SYRINGES FOR STERILE DELIVERY
    K042061 0.9% SODIUM CHLORIDE INJECTION, USP BD POSTFLUSH SF FLUSH SYRINGE
    K032438 MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET PREFILL HEPRIN LOCK FLUSH SYRINGE
    K020996 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    K020999 MEDEFIL'S NORMAL SALINE FLUSH SYRINGE IN VARIOUS FILL SIZES - 1 ML FILL IN 6 ML SYRINGE LL; 2 ML FILL IN 6 ML SYRINGE LL
    K011283 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

    FEI Numbers

    This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.