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Sign in to claim this brandCODAN US Corporation
US
Last updated September 17, 2026
What CODAN US Corporation makes
CODAN US Corporation manufactures single-use intravenous administration products, including tubing extension sets, basic intravenous sets, blood transfusion and transfer sets, enteral tube extensions, fluid bag spikes, and intravenous line stopcocks and filters. These devices are designed for fluid administration, blood handling, and enteral feeding applications in clinical settings.
The company’s portfolio consists of Class II medical devices, all of which are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does CODAN US Corporation manufacture?
CODAN US Corporation specializes in single-use intravenous administration products. Their portfolio includes intravenous tubing extension sets, basic intravenous administration sets, blood transfusion and transfer sets, enteral tube extensions, intravenous fluid bag spikes, and intravenous line stopcocks and filters. These devices are designed for fluid administration, blood handling, and enteral feeding in clinical environments.
Where is CODAN US Corporation based?
CODAN US Corporation is headquartered in the United States. The company’s location is relevant for regulatory and operational purposes, as it aligns with U.S. manufacturing and compliance standards.
Which regulatory registries list CODAN US Corporation’s devices?
CODAN US Corporation’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for healthcare providers, allowing them to verify device details and compliance information.
How are CODAN US Corporation’s devices classified under medical device regulations?
All of CODAN US Corporation’s devices fall under Class II classification. This classification is assigned based on their intended use and risk level, requiring special controls beyond general controls to ensure safety and effectiveness without requiring a premarket approval.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 2001 Sanyo Avenue Suite 130, San Diego, CA, 92154
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3020417125
- DUNS Number
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Catalogue (728)
Page 12 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Codan | B82-50 | FDA UDI | Class II | Active |
| Codan | BC 742 | FDA UDI | Class II | Active |
| Codan | BC 245 | FDA UDI | Class II | Active |
| Codan | B 8901 | FDA UDI | Class II | Active |
| Codan | BC 236 | FDA UDI | Class II | Active |
| Walrus | B 450-W | FDA UDI | Class II | Active |
| Walrus | C 437-W | FDA UDI | Class II | Active |
| Codan | B 307 | FDA UDI | Class II | Active |
| Codan | C 403 | FDA UDI | Class II | Active |
| Codan | EF 122 | FDA UDI | Class II | Active |
| Label Product -codan | B 870 | FDA UDI | Class II | Active |
| Codan | BC 297-EM | FDA UDI | Class II | Active |
| Codan | C 306 | FDA UDI | Class II | Active |
| Codan | BC 697 | FDA UDI | Class II | Active |
| Codan | W20060 | FDA UDI | Class II | Active |
| Walrus | A 416N-W | FDA UDI | Class II | Active |
| Codan | C 467-W | FDA UDI | Class II | Active |
| Codan | LS 430 | FDA UDI | Class II | Active |
| Codan | 95017-E | FDA UDI | Class II | Active |
| Codan | BC 260 | FDA UDI | Class II | Active |
| Label Product -codan | BC158 | FDA UDI | Class II | Active |
| Codan | BC 568 | FDA UDI | Class II | Active |
| Codan | LS 205 | FDA UDI | Class II | Active |
| Codan | BC 633 | FDA UDI | Class II | Active |
| Fresenius Kabi | FK60035KSC | FDA UDI | Class II | Active |
| Codan | BC 2157 | FDA UDI | Class II | Active |
| Codan | BC 2075 | FDA UDI | Class II | Active |
| Codan | BC 639 | FDA UDI | Class II | Active |
| Codan | 95017-D | FDA UDI | Class II | Active |
| Walrus | BC 2029-W | FDA UDI | Class II | Active |
| Codan | BC 569 | FDA UDI | Class II | Active |
| Codan | BC 287 | FDA UDI | Class II | Active |
| Codan | BC 591 | FDA UDI | Class II | Active |
| Codan | BC 2137 | FDA UDI | Class II | Active |
| Codan | A 425N | FDA UDI | Class II | Active |
| Codan | EF 123 | FDA UDI | Class II | Active |
| Label Product -codan | BC111 | FDA UDI | Class II | Active |
| Codan | A476N | FDA UDI | Class II | Active |
| Codan | B321 | FDA UDI | Class II | Active |
| Codan | C 34C | FDA UDI | Class II | Active |
| Rem Systems | BC 2151 | FDA UDI | Class II | Active |
| Walrus | A 438-W | FDA UDI | Class II | Active |
| Walrus | C 404-W | FDA UDI | Class II | Active |
| Fresenius Kabi | FK50062KS | FDA UDI | Class II | Active |
| Codan | BC 593 | FDA UDI | Class II | Active |
| Walrus | B 2025-W | FDA UDI | Class II | Active |
| Codan | B 867 | FDA UDI | Class II | Active |
| Codan | BC2179 | FDA UDI | Class II | Active |
| Codan | BM-97.5840 | FDA UDI | Class II | Active |
| Codan | BC 566 | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
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Importers
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Notified Bodies
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Authorities
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FDA Recalls (2)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
CODAN US Corporation has two FDA recall records, both initiated voluntarily: one on August 17, 2011, and the other on September 12, 2019. Both recalls were terminated. The 2011 recall involved ColorSafe IV product lines due to manufacturing and marketing prior to FDA approval. The 2019 recall addressed potential sterility issues from incomplete or defective seals on individual connector packages.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Sep 12, 2019 | Z-2433-2020 | — | terminated | Individual packages of connectors may have incomplete or bad seals which would compromise sterility. |
| Aug 17, 2011 | Z-2040-2014 | — | terminated | CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval. |