AWI 236-00

GUDID 26972130470535

Disposable Pulse Irrigation Kit

Apex (Suzhou) Medical Products Company

Disposable surgical irrigation/aspiration system

• Primary Device ID: 26972130470535
• NIH Device Record Key: 9bc491b8-8cad-4a0a-877d-70ea029906c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AWI
• Version Model Number: 236-00
• Catalog Number: 236-00
• Company DUNS: 554507451
• Company Name: Apex (Suzhou) Medical Products Company
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• 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	16972130470538 [Unit of Use]
GS1	26972130470535 [Primary]

FDA Product Code

• FQH: Lavage, Jet

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: 2021-04-08
• Device Publish Date: 2021-03-31

On-Brand Devices [AWI]

• 26972130470436: Disposable Pulse Irrigation Kit
• 06972130470418: Hydra Adaptor
• 06972130470401: Tunnel Tip
• 06972130470395: Disposable Irrigation Bag(Apply to Trunk-L)
• 06972130470388: Disposable Irrigation Bag(Apply to Extremity)
• 16972130470439: Disposable Pulse Irrigation Kit
• 16972130470422: Standard Tip
• 06972130470432: Disposable Pulse Irrigation Kit
• 06972130470425: Standard Tip
• 26972130470511: Disposable Pulse Irrigation Kit
• 06972130470517: Disposable Pulse Irrigation Kit
• 06972130470500: Standard Tip
• 16972130470507: Standard Tip
• 16972130470491: Hydra Adaptor
• 16972130470484: Tunnel Tip
• 16972130470477: Disposable Irrigation Bag(Apply to Trunk-L)
• 16972130470460: Disposable Irrigation Bag(Apply to Extremity)
• 16972130470514: Disposable Pulse Irrigation Kit
• 26972130470535: Disposable Pulse Irrigation Kit
• 16972130470538: Disposable Pulse Irrigation Kit
• 06972130470531: Disposable Pulse Irrigation Kit