AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set MRSA60-100

GUDID 40704411004777

AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/MicroClave® Clear, Pre-Slit Port, Rotating Luer, Approx Priming Volume: 12.6mL

AMSINO INTERNATIONAL, INC.

Intravenous administration set

• Primary Device ID: 40704411004777
• NIH Device Record Key: ef45b36a-228b-48b9-95c4-b9123bb9113a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set
• Version Model Number: 1
• Catalog Number: MRSA60-100
• 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	10704411004776 [Primary]
GS1	40704411004777 [Package]; Contains: 10704411004776; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K964435

FDA Product Code

• FMG: Stopcock, I.V. Set

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: 2019-12-11
• Device Publish Date: 2016-09-23

On-Brand Devices [AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set]

• 40704411004791: AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/2 MicroClave® Clear, Rotat
• 40704411004777: AMSafe® 100" (254cm) 60 Drop, Vented/Non-Vented Gravity Admin Set w/MicroClave® Clear, Pre-Sli