Tamper Evident Cap for Luer Lock IV Syringes Bulk Pouch

GUDID B21257302SCA2

Tamper Evident Cap for Luer Lock IV Syringes Bulk Pouch with SCA logo

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap

• Primary Device ID: B21257302SCA2
• NIH Device Record Key: 39c3898d-4d2a-4efe-a2cf-052eab1f66c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap for Luer Lock IV Syringes Bulk Pouch
• Version Model Number: 57-302 SCA
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 10
• 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: true
• 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
HIBCC	B21257302SCA0 [Unit of Use]
HIBCC	B21257302SCA1 [Primary]
HIBCC	B21257302SCA2 [Package]; Contains: B21257302SCA1; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K861276

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-03-29
• Device Publish Date: 2024-03-21

Devices Manufactured by INTERNATIONAL MEDICAL INDUSTRIES INC.

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• B21257302RSTAQ20 - Tamper Evident Cap: 2025-03-12 Tamper Evident Cap - STAQ Logo - Tyvek Pouch
• B21257302RSTAQ30 - Tamper Evident Cap: 2025-03-12 Tamper Evident Cap - STAQ Logo - Box
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• B21257302WSTAQ20 - Tamper Evident Cap: 2025-03-12 Tamper Evident Cap - STAQ Logo Tyvek Pouch