AMSure®Sterile Normal Saline for Wound Flush AS398-1

GUDID 00704411010350

AMSure® Sterile Normal Saline 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 normal saline 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: 00704411010350
• NIH Device Record Key: b99e8ae0-2370-4c5d-92bf-2edec9da232f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSure®Sterile Normal Saline for Wound Flush
• Version Model Number: 1
• Catalog Number: AS398-1
• 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	00704411010350 [Primary]
GS1	40704411010358 [Package]; 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: 2019-02-18

Devices Manufactured by AMSINO INTERNATIONAL, INC.

• 40704411016596 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 3mL, use only in flushing compatible intravenous administration sets and indwe
• 40704411016602 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 5mL, use only in flushing compatible intravenous administration sets and indwe
• 40704411016619 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, 10mL, use only in flushing compatible intravenous administration sets and indw
• 40704411016626 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 3mL, use only in flushing compatible intravenous administ
• 40704411016633 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 5mL, use only in flushing compatible intravenous administ
• 40704411016640 - AMSafe ® Pre-Filled Normal Saline Flush Syringe: 2023-09-08 AMSafe ® Pre-Filled Normal Saline Flush Syringe, STERILE FIELD READY, 10mL, use only in flushing compatible intravenous adminis
• 40704411016244 - AMSafe ® I.V Administration Set 100'': 2023-08-28 For use with Spectrum, Flo-Gard 6201 and 6301 series pumps 100” (2.5m), 10 drops/mL, Slide and Roller Clamp, 1.2 Micron Filter
• 40704411016152 - AMSure ® Enteral Administration Kit: 2023-06-01 Enteral Administration Kit FOR USE WITH AMSure® ENTERAL FEEDING PUMP CONTENTS: -Enteral Feeding 500 mL Bag Pump Set with ENFit