Guarded Luer Connector Female to Male 57-401

GUDID B212574012

Guarded Luer Connector Female to Male, Yellow, Sterile, Box of 50 individual blisters.

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer/Luer linear connector, single-use

• Primary Device ID: B212574012
• NIH Device Record Key: 02afeef7-a85b-415d-bafb-d1e918ff1e7a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guarded Luer Connector Female to Male
• Version Model Number: 57-401
• Catalog Number: 57-401
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 50
• 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: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B212574010 [Unit of Use]
HIBCC	B212574011 [Primary]
HIBCC	B212574012 [Package]; Contains: B212574011; Package: Box [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173577

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-10-29

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