Tamper Evident Additive Port Cap 21-03-100

GUDID B21221031002

"For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bags of 50, 2 bags per shipper box"

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap

• Primary Device ID: B21221031002
• NIH Device Record Key: b3597b8f-8ffa-48f0-9a87-9ea2084a70df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tamper Evident Additive Port Cap
• Version Model Number: 21-03-100
• Catalog Number: 21-03-100
• 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: 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	B21221031000 [Unit of Use]
HIBCC	B21221031001 [Primary]
HIBCC	B21221031002 [Package]; Contains: B21221031001; Package: Box [2 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190305

FDA Product Code

• KPE: Container, I.V.

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: 2022-10-18
• Device Publish Date: 2022-10-10

On-Brand Devices [Tamper Evident Additive Port Cap]

• B21221031002: "For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that
• B21221032: "For use on the medication port of ICU Medical LifeCare ® to provide both visual evidence that