FDA 510(k)

MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE

K-Number: K091583 · 2010-01-28

Decision Date2010-01-28

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is Medefil, Inc.. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K091583. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE?

MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Medefil, Inc.. The 510(k) number is K091583.

When did MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE receive FDA 510(k) clearance?

MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE received FDA 510(k) clearance on 2010-01-28, under 510(k) number K091583.

Who is the listed applicant for MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE?

The FDA 510(k) record lists Medefil, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE?

The FDA product code for MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE is NGT.

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Other records listing Medefil, Inc. as applicant

K121262MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY K092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES K020996MEDEFIL'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 K020999MEDEFIL'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 K993518MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE LL K993515MEDEFIL'S NORMAL SALINE FLUSH SYRINGE, IN VARIOUS FILL SIZES - 1 ML FILL IN 3 ML SYRINGE LL; 1 ML FILL IN 6 ML SYRINGE L

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Related Devices (Code: NGT)

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and Company K233623Praxiject™ SP 0.9% NaClMedxl, Inc.K231724Flush Syringe (Prefilled 0.9% normal saline solution)Spm Medicare Pvt. , Ltd.K231363Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010)Hantech Medical Device Co., Ltd.K230756TK Pre-Filled Normal Saline Flush SyringeAnhui Tiankang Medical Technology Co., Ltd.K223584Pre-Filled Normal Saline Flush SyringeAnhui Tianyang Pharmaceutical Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.