Identity
- Trade Name
- Additive Port Cap FDA UDI
- Generic Name
- Luer-formatted protective cap FDA UDI
- Device Name
- "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" FDA UDI
- Model / Reference
- 21-00B-100 FDA UDI
- Description
- "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" FDA UDI
Identifiers
- Catalog Number
- 21-00B-100 FDA UDI
- Primary DI / UDI-DI
- B2122100B1001 FDA UDI
- 510(k) Number
- K190305 FDA UDI
- FDA Product Code
- KPE FDA UDI
- GMDN Term
- Luer-formatted protective cap FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.5025 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Luer-formatted protective cap
Additive Port Cap by International Medical Industries Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K190305 also covers:
- Additive Port Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Additive Port Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Additive Port Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Additive Port Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
- Tamper Evident Additive Port Cap — INTERNATIONAL MEDICAL INDUSTRIES INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- International Medical Industries Inc.
Sources (1)
- FDA UDI b2999d11-1cf8-455e-ae90-d38eea3ac6a3 35 fields · synced Jun 8, 2026