AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber

GUDID 40704411007501

AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 7" attached extension set. One Split Septum Injection Site, One Needle-Free Injection Site, One Rotating Male Luer Lock Adapter Length=82”, Priming Volume=22ml Non-Pyrogenic fluid pathway. GRAVITY USE ONLY

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411007501
• NIH Device Record Key: 679d40a3-3872-4bb6-8dc6-8bff751ac44c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber
• Version Model Number: 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: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10704411007500 [Primary]
GS1	40704411007501 [Package]; Contains: 10704411007500; 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: 3
• Public Version Date: 2019-12-11
• Device Publish Date: 2018-03-30

On-Brand Devices [AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber]

• 40704411007501: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 7" attache
• 40704411004074: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 6" attache
• 40704411004067: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 12" attach
• 40704411004050: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 7" attache
• 40704411004043: AMSafe-3 EXT6 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 6" (1
• 40704411004036: AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber Non-Pyrogenic f