Identity
- Trade Name
- XLR8 200 CC Canister EUDAMEDXLR8 Canister FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- XLR8 200 cc Canister EUDAMEDAll canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates. FDA UDI
- Model / Reference
- A4-S00D2 EUDAMEDFDA UDI
- Description
- All canisters are made out of ABS material. It is used as a disposable item to collect patient’s exudates. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405000396 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405000396 EUDAMED
- 510(k) Number
- K143726 FDA UDI
- FDA Product Code
- OMP FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Negative-pressure wound therapy system canister FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4780 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Negative-pressure wound therapy system canister
XLR8 Canister by Genadyne Biotechnologies, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K143726 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Genadyne Biotechnologies, Inc.
Sources (2)
- FDA UDI 36b84ab8-0ffb-4a17-b2fb-cfbfd8f62691 34 fields · synced Jul 14, 2026
- EUDAMED a533409a-d8ac-445a-8e5d-05e5f0c5ff7d 61 fields · synced Jul 14, 2026