Tamper Evident Cap for Luer Lock IV Syringes

GUDID B21257352B0

Tamper Evident Cap for Luer Lock IV Syringes

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap

• Primary Device ID: B21257352B0
• NIH Device Record Key: 9bd8ec82-7ebc-49d7-a8a9-0cb2216b509b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap for Luer Lock IV Syringes
• Version Model Number: 57-352 B
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 210
• 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	B21257352B0 [Unit of Use]
HIBCC	B21257352B1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182545

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: 2023-08-08
• Device Publish Date: 2023-07-31

On-Brand Devices [Tamper Evident Cap for Luer Lock IV Syringes]

• B21257352W0: Tamper Evident Cap for Luer Lock IV Syringes
• B21257352R0: Tamper Evident Cap for Luer Lock IV Syringes
• B21257352B0: Tamper Evident Cap for Luer Lock IV Syringes
• B21257302W2: Tamper Evident Cap for Luer Lock IV Syringes
• B21257302R2: Tamper Evident Cap for Luer Lock IV Syringe
• B21257302B0: Tamper Evident Cap for Luer Lock IV Syringes
• B2125726SCA2: Tamper Evident Cap for Luer Lock IV Syringes with SCA logo