AMSafe® MicroClave® multi-Dose vial Access spike MB4V01

GUDID 40704411004517

AMSafe® MicroClave® multi-Dose vial Access spike, Approx Priming volume: 0.16mL

AMSINO INTERNATIONAL, INC.

Vial/bottle adaptor, non-hermetic

• Primary Device ID: 40704411004517
• NIH Device Record Key: a55cfdd7-8a0b-42d3-a36e-e509117c3a5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe® MicroClave® multi-Dose vial Access spike
• Version Model Number: 1
• Catalog Number: MB4V01
• 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411004516 [Primary]
GS1	40704411004517 [Package]; Contains: 10704411004516; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081361

FDA Product Code

• FPA: Set, Administration, Intravascular

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-22
• Device Publish Date: 2016-09-23

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