Additive Port Cap 21-00-100

GUDID B21221001000

"For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL-IN-ONE EVA containers to provide both visual evidence that medication has been added and tamper evidence once the device is closed. Packaged in Non-Sterile Bag of 100, 1 bag per shipper box"

INTERNATIONAL MEDICAL INDUSTRIES INC.

Luer-formatted protective cap

• Primary Device ID: B21221001000
• NIH Device Record Key: 75019a3a-c3eb-4e73-a2bd-c236db2137e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Additive Port Cap
• Version Model Number: 21-00-100
• Catalog Number: 21-00-100
• 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: 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	B21221001000 [Unit of Use]
HIBCC	B21221001001 [Primary]
HIBCC	B21221001002 [Package]; Contains: B21221001001; Package: Box [1 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: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-10-07
• Device Publish Date: 2022-09-29

On-Brand Devices [Additive Port Cap]

• B21221002: "For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
• B2122100B1000: "For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
• B2122100B2: "For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
• B21221001000: "For use on the medication port of Baxter VIAFLEX, Baxter INTRAVIA, Baxter AVIVA, and Baxter ALL
• B21221021002: B. Braun Excel Additive Port Cap
• B21221022: B. Braun Excel Additive Port Cap
• B2122101B1002: 21-01B 100
• B2122101B2: Tamper Evident Additive Port Cap for IV Bags - Fresenius Kabi, Non-Sterile
• B21221012: Tamper Evident Additive Port Cap for IV Bags - B. Braun PAB/E3, Non-Sterile
• B21221011000: 100 Unit configuration of Additive Port Cap for B. Braun IV Bags