AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber D38304

GUDID 40704411004067

AMSafe-3 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber with 12" attached extension set Non-Pyrogenic fluid pathway GRAVITY USE ONLY. Backcheck Valve. Two Split Septum Injection Sites. One Needle-Free Injection Site. One Rotating Male Luer Lock Adapter

AMSINO INTERNATIONAL, INC.

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• Primary Device ID: 40704411004067
• NIH Device Record Key: 1401993c-a312-47d9-a5bd-75f106571fb8
• 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
• Catalog Number: D38304
• 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	10704411004066 [Primary]
GS1	40704411004067 [Package]; Contains: 10704411004066; 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 Non-Vented I.V. Set with 10, 15, or 60 drops/ml Selectable Drip Chamber]

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• 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