AMSafe-3® I.V. Administration Set MR8302

GUDID 40704411005279

AMSafe-3® I.V. Administration Set 91" (231 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravity Admin Set with 2 Pre-Slit Ports, 2 MicroClave® Clear, 1 Ext. Set, Slide Clamp, Rotating Male Luer Lock. Approx. Priming Volume: 25mL

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411005279
• NIH Device Record Key: 488b038f-ab20-4651-a9c8-d9e83244541f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe-3® I.V. Administration Set
• Version Model Number: 1
• Catalog Number: MR8302
• 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	10704411005278 [Primary]
GS1	40704411005279 [Package]; Contains: 10704411005278; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K101958

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

On-Brand Devices [AMSafe-3® I.V. Administration Set]

• 40704411005286: AMSafe-3® I.V. Administration Set 91" (231 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravity Ad
• 40704411005279: AMSafe-3® I.V. Administration Set 91" (231 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravity Ad
• 40704411005262: AMSafe-3® I.V. Administration Set 83" (211 cm) Adjusts to 10, 15, 60 Drop Non-Vented Gravity Ad