Disposable Infusion Bag for Parenteral Nutrition

GUDID 06945326839542

The proposed device is for use in compounding and storage of parenteral nutrition solutions prior to and during administration to a patient using an intravascular administration set. The proposed device is provided sterile and single use.

Beijing L&Z Medical Technology Development Co., Ltd

Intravenous administration bag/bottle

• Primary Device ID: 06945326839542
• NIH Device Record Key: cc50548e-5f05-46e9-962f-08a318c11dca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Infusion Bag for Parenteral Nutrition
• Version Model Number: BEDX
• Company DUNS: 545213456
• Company Name: Beijing L&Z Medical Technology Development 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06945326839542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222622

FDA Product Code

• KEP: Media, Mounting, Oil Soluble

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: 2024-10-07
• Device Publish Date: 2024-09-27

On-Brand Devices [Disposable Infusion Bag for Parenteral Nutrition]

• 06945326839542: The proposed device is for use in compounding and storage of parenteral nutrition solutions prio
• 06945326839559: The proposed device is for use in compounding and storage of parenteral nutrition solutions prio