AQUILAVIE HEALTHCARE

GUDID 06936018500413

Anhui Kangda Medical Products Co.,Ltd.

General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle General-purpose syringe/needle

• Primary Device ID: 06936018500413
• NIH Device Record Key: a6b2b7a4-b370-4ce7-89e4-f5cd1dfcf518
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AQUILAVIE HEALTHCARE
• Version Model Number: AQINJ-LS01-2525
• 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: 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	06936018500390 [Unit of Use]
GS1	06936018500406 [Primary]
GS1	06936018500413 [Package]; Contains: 06936018500406; Package: Case [3200 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083686

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

[06936018500413]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-21
• Device Publish Date: 2021-06-11

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