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UNO Plus 200 CC Collection Canister
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref UP-S00D2
Identity
- Trade Name
- UNO+ 200 CC EUDAMEDUNO Plus 200 CC Collection Canister FDA UDI
- Generic Name
- Negative-pressure wound therapy system canister FDA UDI
- Device Name
- UNO Plus 200 CC Collection Canister EUDAMEDAll canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: 200cc (Ref#: UP-S00D2) 300cc (Ref#: UP-S00D3) Each canister is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375” side and chevron seals). The canister is sterilized using EO sterilization method and has a shelf life of 3 years. FDA UDI
- Model / Reference
- UP-S00D2 EUDAMEDFDA UDI
- Description
- All canisters are made out of ABS material. It is use as a disposable item to collect patient’s exudates. It comes in 2 sizes: 200cc (Ref#: UP-S00D2) 300cc (Ref#: UP-S00D3) Each canister is individually packaged in a medical grade Tyvek pouch (1073B Tyvek and a polyester/polyethylene laminate with a 0.375” side and chevron seals). The canister is sterilized using EO sterilization method and has a shelf life of 3 years. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00849405000389 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00849405000389 EUDAMED
- 510(k) Number
- K210107 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
- Spain 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
No
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
Ethylene Oxide FDA UDI
Category: Negative-pressure wound therapy system canister
UNO Plus 200 CC Collection 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
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 e6436c5b-99c5-4d09-8dfd-f0f2e53c9146 34 fields · synced Jul 21, 2026
- EUDAMED e317ccd8-228c-4983-bfbf-3cd480b3f66b 61 fields · synced Jul 21, 2026