Wealy

GUDID 06971603585239

The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and a fluid transfer device. It is used to deliver fluids into the body orally or enterally. It is intended to be used multiple times in non-clinical settings by users ranging from clinicians to laypersons in all age groups. The device is indicated for single patient use only.

Shantou Wealy Medical Instrument Co., Ltd.

ENFit oral/enteral syringe, reusable

• Primary Device ID: 06971603585239
• NIH Device Record Key: 4b39233b-5300-49e1-8a90-d5c2ea84647e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Wealy
• Version Model Number: 60ml
• Company DUNS: 545570186
• Company Name: Shantou Wealy Medical Instrument Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971603585222 [Primary]
GS1	06971603585239 [Package]; Contains: 06971603585222; Package: box [60 Units]; In Commercial Distribution
GS1	06971603585246 [Package]; Package: carton [4 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203613

FDA Product Code

• KCP: Syringe, Ent
• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-21
• Device Publish Date: 2022-10-13

On-Brand Devices [Wealy]

• 06971603580319: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580357: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580340: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580289: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580371: Auto-retractable syringe. When the medication is fully discharge, the needle will be auto-retrac
• 06971603580517: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580586: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603580531: Auto-retractable syringe. When the medication is fully discharged, the needle will be auto-retra
• 06971603585239: The ENFit® Reusable Enteral Syringe is indicated for use as a dispenser, a measuring device and