Identity
- Trade Name
- CC1 Wound Drainage pump FDA UDI
- Generic Name
- Negative-pressure wound therapy system, electric, reusable FDA UDI
- Device Name
- The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as the device may promote wound healing. FDA UDI
- Model / Reference
- XL FDA UDI
- Description
- The Exsudex® Wound Drainage Device is a compact, portable device indicated for patients who would benefit from the application of negative pressure to the area of a wound, for the aspiration and removal of surgical fluids, irrigation fluids, tissue (including bone), gases, bodily fluids or infectious materials either during surgery or at the patient’s bedside particularly as the device may promote wound healing. FDA UDI
Identifiers
- Catalog Number
- 3000700-CCT FDA UDI
- Primary DI / UDI-DI
- 08718104890459 FDA UDI
- 510(k) Number
- K082311 FDA UDI
- GMDN Term
- Negative-pressure wound therapy system, electric, reusable FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Negative-pressure wound therapy system, electric, reusable
CC1 Wound Drainage pump by Meditop B.V. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K082311 also covers:
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Meditop B.V.
Sources (1)
- FDA UDI ec888b06-8aee-487a-a199-7d0025133361 37 fields · synced Jun 8, 2026