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FDA 510(k)

MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE

K-Number: K011283 · 2001-10-15

ApplicantThe Kendall Company
Decision Date2001-10-15
Product CodeNGT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE is the device name listed in this FDA 510(k) record. The listed applicant is The Kendall Company. It received FDA 510(k) clearance on 2001-10-15 under 510(k) number K011283. 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 MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE is a medical device that received FDA 510(k) clearance on 2001-10-15. The listed applicant is The Kendall Company. The 510(k) number is K011283.

When did MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE receive FDA 510(k) clearance?

MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE received FDA 510(k) clearance on 2001-10-15, under 510(k) number K011283.

Who is the listed applicant for MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

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

What is the FDA product code for MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE?

The FDA product code for MONOJECT PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE is NGT.

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Other records listing The Kendall Company as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061936KENDALL ARGYLE NEONATAL/PEDIATRIC PICC, MODEL 43311K030209MAHURKAR OPLUS CATHETER, MODEL 13.5 FRK020089MAHURKAR TRIPLE LUMEN CATHETER, 12 FRK011941EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088K002902TANDEM-CATH 10 FR. CATHETER SYSTEM, MODEL MULTIPLE CODE NUMBERSK002901KENDALL 14.5 FR MAXID CUFFED DUAL LUMEN CATHETER

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Related Devices (Code: NGT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K2508840.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP SyringeBecton, Dickinson and CompanyK233623Praxiject™ 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.

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