FDA 510(k)

MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY

K-Number: K121262 · 2012-09-20

Decision Date2012-09-20

Product CodeNGT

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY is the device name listed in this FDA 510(k) record. The listed applicant is Medefil, Inc.. It received FDA 510(k) clearance on 2012-09-20 under 510(k) number K121262. 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 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY?

MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY is a medical device that received FDA 510(k) clearance on 2012-09-20. The listed applicant is Medefil, Inc.. The 510(k) number is K121262.

When did MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY receive FDA 510(k) clearance?

MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY received FDA 510(k) clearance on 2012-09-20, under 510(k) number K121262.

Who is the listed applicant for MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY?

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 MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY?

The FDA product code for MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY is NGT.

Related Clinical Trials

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Other records listing Medefil, Inc. as applicant

K092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES K091583MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE 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

View on FDA Database →

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