Cardinal Health 412SE

GUDID 16971564466230

The 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 in clinical or home care settings by users ranging from clinicians to laypersons (under the supervision of a clinician) in all age groups.

Jiangsu Caina Medical Co.,Ltd

ENFit oral/enteral syringe, single-use

• Primary Device ID: 16971564466230
• NIH Device Record Key: 4a108ef5-7bc9-484b-8e79-557e70669b2d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cardinal Health
• Version Model Number: 12ml
• Catalog Number: 412SE
• Company DUNS: 544543513
• Company Name: Jiangsu Caina Medical 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: true
• 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	06971564466233 [Primary]
GS1	16971564466230 [Package]; Contains: 06971564466233; Package: [80 Units]; In Commercial Distribution
GS1	26971564466237 [Package]; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190502

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-14
• Device Publish Date: 2023-07-06

On-Brand Devices [Cardinal Health]

• 16971564466254: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564466247: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564466230: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564466223: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564466216: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564466209: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466868: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466851: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466844: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466837: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466820: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 06971564466813: The Enteral Syringe is indicated for use as a dispenser, a measuring device, and a fluid transfe
• 16971564467541: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai
• 16971564467534: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai
• 16971564467527: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai
• 16971564467497: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai
• 16971564467480: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai
• 16971564467473: Safety disposable insulin syringe is intended to inject U-100 insulin into the human body and ai