Tamper Evident Cap with ENFit 57-220-100

GUDID B21257220100

Tamper Evident Cap for Use With ENFit® Syringes (ETEC)

INTERNATIONAL MEDICAL INDUSTRIES INC.

ENFit-formatted protective cap

• Primary Device ID: B21257220100
• NIH Device Record Key: b35479a8-0ec6-4754-bda4-e7144f3307bc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap with ENFit
• Version Model Number: 57-220-100
• Catalog Number: 57-220-100
• Company DUNS: 053469565
• Company Name: INTERNATIONAL MEDICAL INDUSTRIES INC.
• Device Count: 100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B21257220100 [Package]; Contains: B212572201001; Package: Bag [100 Units]; In Commercial Distribution
HIBCC	B212572201000 [Unit of Use]
HIBCC	B212572201001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170672

FDA Product Code

• PNR: Enteral Syringes With Enteral Specific Connectors

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-07-20
• Device Publish Date: 2023-07-12

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