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Sign in to claim this brandCAREFUSION 2200, INC.
US
Last updated September 17, 2026
What CAREFUSION 2200, INC. makes
The company produces single-use medical devices for diagnostic and drainage procedures, including bone marrow biopsy kits and needles (e.g., Jamshidi), pleural/peritoneal drainage catheterization kits (e.g., PleurX), aspiration trays, peritoneovenous shunts, soft-tissue biopsy kits, and subcutaneous tunnellers. Interventional radiology percutaneous-access kits are also part of the portfolio, alongside specialized tools like the Safe-T-Centesis and ClipVac.
These devices are classified under FDA regulations as Class I or Class II, with some authorised via the 510(k) pathway and others under the Unique Device Identification (UDI) system. The company’s products are listed in the FDA’s regulatory databases, reflecting their compliance with US medical device requirements.
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 CareFusion 2200, Inc. manufacture?
CareFusion 2200, Inc. specializes in single-use medical devices primarily for diagnostic and drainage procedures. Their portfolio includes bone marrow biopsy procedure kits and needles (like the Jamshidi), pleural and peritoneal drainage catheterization kits (such as PleurX), aspiration trays, peritoneovenous shunts, soft-tissue biopsy kits, subcutaneous tunnellers, and interventional radiology percutaneous-access kits. These devices are designed for procedures requiring precise access, drainage, or tissue sampling.
Where is CareFusion 2200, Inc. based, and how does that affect its regulatory standing?
CareFusion 2200, Inc. is based in the United States, which means its devices are subject to FDA regulations. The company’s products are listed in the FDA’s databases, including the 510(k) and Unique Device Identification (UDI) systems, indicating they meet US regulatory requirements for medical devices. This reflects compliance with the FDA’s framework for device authorization in the US market.
Which regulatory registries or databases list CareFusion 2200, Inc.’s devices?
CareFusion 2200, Inc.’s devices are listed in the FDA’s regulatory databases, specifically under the 510(k) pathway and the Unique Device Identification (UDI) system. These registries document the authorization status of individual devices, ensuring transparency about their compliance with US medical device regulations. The inclusion in these systems confirms the devices meet FDA requirements for safety and performance.
How are CareFusion 2200, Inc.’s devices classified under FDA regulations?
CareFusion 2200, Inc.’s devices are classified under the FDA’s regulatory framework as either Class I or Class II. Class I devices generally pose the lowest risk and may require general controls, while Class II devices involve moderate risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway—such as 510(k) clearance or UDI compliance—each device must follow to be authorized for use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 75 North Fairway Drive, Vernon Hills, IL, 60061
- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
- —
- FDA FEI Number
- 3008002452
- DUNS Number
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Catalogue (2391)
Page 21 of 48| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| V. Mueller | OP7060 | FDA UDI | Class I | Unknown |
| V. Mueller | 89-2357 | FDA UDI | Class I | Unknown |
| Snowden-Pencer | 32-5456 | FDA UDI | Class I | Unknown |
| V. Mueller | SP90-8932 | FDA UDI | Class II | Unknown |
| V. Mueller | HY23135 | FDA UDI | Class II | Unknown |
| V. Mueller | RH551-331 | FDA UDI | Class I | Unknown |
| V. Mueller | GU8260-009 | FDA UDI | Class I | Unknown |
| V. Mueller | OP3230 | FDA UDI | Class I | Unknown |
| Snowden-Pencer | SP90-5215 | FDA UDI | Class II | Unknown |
| V. Mueller | OP7551-MM | FDA UDI | Class I | Unknown |
| Snowden-Pencer | 32-4430 | FDA UDI | Class I | Unknown |
| V. Mueller | 256.21030B | FDA UDI | Class II | Unknown |
| V. Mueller | OP0924-201 | FDA UDI | Class I | Unknown |
| V. Mueller | SP90-5014 | FDA UDI | Class II | Unknown |
| V. Mueller | MO11072 | FDA UDI | Class I | Unknown |
| V. Mueller | MO9794 | FDA UDI | Class I | Unknown |
| V. Mueller | SU2981-002 | FDA UDI | Class II | Unknown |
| Denver | 42-2322 | FDA UDI | Class II | Active |
| V. Mueller | F256.81010 | FDA UDI | Class II | Unknown |
| V. Mueller | NA1901 | FDA UDI | Class II | Unknown |
| V. Mueller | SP90-8236 | FDA UDI | Class II | Unknown |
| Temno | ACT2020 | FDA UDI | Class II | Unknown |
| Tru-Cut | 2N2713X | FDA UDI | Class II | Unknown |
| V. Mueller | SP90-8214 | FDA UDI | Class II | Unknown |
| V. Mueller | SU620 | FDA UDI | Class I | Unknown |
| V. Mueller | S-1442 | FDA UDI | Class II | Unknown |
| V. Mueller | CH8109-23 | FDA UDI | Class I | Unknown |
| V. Mueller | SP90-7135 | FDA UDI | Class II | Unknown |
| Snowden-Pencer | SP94-8464 | FDA UDI | Class II | Unknown |
| Snowden-Pencer | 32-5398 | FDA UDI | Class I | Unknown |
| V. Mueller | SP90-8035 | FDA UDI | Class II | Unknown |
| Snowden-Pencer | SP96-8385 | FDA UDI | Class II | Unknown |
| V. Mueller | CL1388-BLACK | FDA UDI | Class II | Unknown |
| V. Mueller | SP90-2203 | FDA UDI | Class II | Unknown |
| V. Mueller | NA1900 | FDA UDI | Class II | Unknown |
| V. Mueller | SP90-2108 | FDA UDI | Class II | Unknown |
| V. Mueller | U-0701 | FDA UDI | Class II | Unknown |
| Denver | 42-2321 | FDA UDI | Class II | Active |
| V. Mueller | CD5-3B-GOLD | FDA UDI | Class II | Unknown |
| Snowden-Pencer | SP90-4206 | FDA UDI | Class II | Unknown |
| Snowden-Pencer | SP90-3017 | FDA UDI | Class II | Unknown |
| V. Mueller | EBP23150-F | FDA UDI | Class II | Unknown |
| V. Mueller | LA1010-1 | FDA UDI | Class II | Unknown |
| Snowden-Pencer | 88-1049 | FDA UDI | Class I | Unknown |
| Snowden-Pencer | SP90-7204 | FDA UDI | Class II | Unknown |
| V. Mueller | RH4332 | FDA UDI | Class I | Unknown |
| V. Mueller | SP90-3117 | FDA UDI | Class II | Unknown |
| V. Mueller | 256.15020B | FDA UDI | Class II | Unknown |
| V. Mueller | NL1175-003 | FDA UDI | Class I | Unknown |
| Temno | T209 | FDA UDI | Class II | Unknown |
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