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FDA 510(k)

PUGGLE Enteral Feeding Pump and Feeding Set

K-Number: K200051 · 2020-09-25

ApplicantAmsino International, Inc.
Decision Date2020-09-25
Product CodeLZH
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PUGGLE Enteral Feeding Pump and Feeding Set is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2020-09-25 under 510(k) number K200051. The device is classified under product code LZH. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PUGGLE Enteral Feeding Pump and Feeding Set?

PUGGLE Enteral Feeding Pump and Feeding Set is a medical device that received FDA 510(k) clearance on 2020-09-25. The listed applicant is Amsino International, Inc.. The 510(k) number is K200051.

When did PUGGLE Enteral Feeding Pump and Feeding Set receive FDA 510(k) clearance?

PUGGLE Enteral Feeding Pump and Feeding Set received FDA 510(k) clearance on 2020-09-25, under 510(k) number K200051.

Who is the listed applicant for PUGGLE Enteral Feeding Pump and Feeding Set?

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

What is the FDA product code for PUGGLE Enteral Feeding Pump and Feeding Set?

The FDA product code for PUGGLE Enteral Feeding Pump and Feeding Set is LZH.

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Other records listing Amsino International, Inc. as applicant

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K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure Enteral Feeding PumpK220267AMSafe NeuFlo Needleless ConnectorK213522AMSafe Pre-Filled Normal Saline Flush SyringeK183473AMSafe(R) Pre-Filled Normal Saline Flush SyringeK181445AMSure Hydrophilic Intermittent Catheter

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Related Devices (Code: LZH)

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.

K253558Luminoah FLOW™ Enteral Nutrition SystemLuminoahK232205Vesco Q™ Enteral Feeding Pump; Vesco Q™ 500mL Bag Feed Set; Vesco Q™ 1000mL Bag Feed Set; Vesco Q™ 40mm Screw Cap Feed Set; Vesco Q™ ENPlus Feed SetVesco Medical, LLCK221603Kangaroo OMNI™ Enteral Feeding Pump (385400 );Kangaroo OMNI™ Feeding Set 500ml (B5FD );Kangaroo OMNI™ ENtelliSet 500ml (E5FD );Kangaroo OMNI™ Feeding Set 1000ml (B10FD );Kangaroo OMNI™ ENtelliSet 1000ml (E10FD );Kangaroo OMNI™ ENPlus Spike Set (BSPFD );Kangaroo OMNI™ ENtelliSet ENPlus Spike ( ESPFD );Kangaroo OMNI™ Feeding Set 500ml with Flush Bag ( B5FF);Kangaroo OMNI™ ENtelliSet 500ml with Flush Bag (E5FF);Kangaroo OMNI™ Feeding Set 1000ml with Flush Bag ( E10FF );Kangaroo OMNI™Cardinal Health, LLCK220230AMSure Enteral Feeding PumpAmsino International, Inc.K153074Kangaroo Connect Enteral Feeding Pump with Kangaroo Connect Feeding Sets, Kangaroo Connect PortalCovidien

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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