Tamper Evident Cap for use with ENFit Syringes 57-220

GUDID B212572201

Tamper Evident Cap for use with ENFit Syringes, Purple. Non-sterile. Bag of 100. Package of 1000. Provides positive closure and tamper evidence.

INTERNATIONAL MEDICAL INDUSTRIES INC.

Syringe tip cap

• Primary Device ID: B212572201
• NIH Device Record Key: 79c57b91-ca93-4130-a8ad-1a3cfb8c6bac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Cap for use with ENFit Syringes
• Version Model Number: 57-220
• Catalog Number: 57-220
• 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: false
• Expiration Date: false
• 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	B212572200 [Unit of Use]
HIBCC	B212572201 [Primary]
HIBCC	B212572202 [Package]; Package: Box [1000 Units]; In Commercial Distribution

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-10-26

On-Brand Devices [Tamper Evident Cap for use with ENFit Syringes]

• B21257220R2: Tamper evident cap for use with ENFit syringes; red; non-sterile; bag of 100; package of 1000; p
• B212572201: Tamper Evident Cap for use with ENFit Syringes, Purple. Non-sterile. Bag of 100. Package of 1