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510(k) Data Aggregation
K Number
K201286Device Name
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
Manufacturer
Nurse Assist, LLC
Date Cleared
2020-08-11
(89 days)
Product Code
NGT
Regulation Number
880.5200Why did this record match?
Applicant Name (Manufacturer) :
Nurse Assist, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations for the appropriate device. May be placed on a sterile field.
Device Description
The 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery is a sterile, single-use, prefilled 12 mL syringe containing 10 mL of 0.9% Sodium Chloride Injection, USP. The pre-filled syringes are provided in two packaging configurations: 1) single syringe or 2) two (2) syringes. The device may be used in the sterile field as they are sterilized post-packaging.
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