AQUILAVIE

GUDID 06936018500888

Anhui Kangda Medical Products Co.,Ltd.

General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use

• Primary Device ID: 06936018500888
• NIH Device Record Key: a988c8f0-c3ae-4c7e-9b93-11567bddae34
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUILAVIE
• Version Model Number: J10003
• Company DUNS: 529827552
• Company Name: Anhui Kangda Medical Products Co.,Ltd.
• Device Count: 100
• 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: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06936018500888 [Package]; Contains: 06936018500895; Package: [800 Units]; In Commercial Distribution
GS1	06936018500895 [Primary]
GS1	06936018500901 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083686

FDA Product Code

• FMF: Syringe, Piston

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: 2022-10-19
• Device Publish Date: 2022-10-11

Devices Manufactured by Anhui Kangda Medical Products Co.,Ltd.

• 06936018501625 - BAIXIN: 2024-03-12
• 06936018501656 - BAIXIN: 2024-03-12
• 06936018501687 - BAIXIN: 2024-03-12
• 06936018501717 - BAIXIN: 2024-03-12
• 06936018501748 - BAIXIN: 2024-03-12
• 06936018501779 - BAIXIN: 2024-03-12
• 06936018501809 - BAIXIN: 2024-03-12
• 06936018501830 - BAIXIN: 2024-03-12