AMSure®Sterile Water for Wound Flush AS399-1

GUDID 40704411010365

AMSure® Sterile Water for Wound Flush devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. Sterile Water for wound flush are intended to be used in home care and should only be used by clinicians familiar with the treatment of possible complications.

AMSINO INTERNATIONAL, INC.

Wound irrigation sterile saline

• Primary Device ID: 40704411010365
• NIH Device Record Key: ffca8f7c-fa87-4d97-9e25-8848d89e0993
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure®Sterile Water for Wound Flush
• Version Model Number: 1
• Catalog Number: AS399-1
• Company DUNS: 825673239
• Company Name: AMSINO INTERNATIONAL, INC.
• 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: false
• 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	00704411010367 [Primary]
GS1	40704411010365 [Package]; Contains: 00704411010367; Package: case [48 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181423

FDA Product Code

• FRO: Dressing, Wound, Drug

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-12-02
• Device Publish Date: 2019-02-19

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