Dbp-1000
EUDAMEDFDA UDIClass I (EU MDR)
by GBUK Group
Identity
- Trade Name
- Enteral FDA UDI
- Generic Name
- Gastric drainage/decompression bag FDA UDI
- Device Name
- Enteral, Drainage Bag, PVC, Single Use 1000ml FDA UDI
- Model / Reference
- DBP-250 EUDAMEDDBP-1000 EUDAMEDFDA UDI
- Description
- Enteral, Drainage Bag, PVC, Single Use 1000ml FDA UDI
Identifiers
- Catalog Number
- DBP-1000 FDA UDI
- Primary DI / UDI-DI
- 05060590880852 EUDAMEDFDA UDI
- Basic UDI-DI
- 506059088EntDrainBagNS9M EUDAMED
- FDA Product Code
- FFD FDA UDI
- EMDN Code
- A060301 COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE EUDAMED
- GMDN Term
- Gastric drainage/decompression bag FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.4370 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
Category: Negative-pressure wound therapy system canister
Dbp-1000 by GBUK Group — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Negative-pressure wound therapy system canister.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 506059088EntDrainBagNS9M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- GBUK Group
- EUDAMED SRN
- GB-MF-000002238
- Authorised Representative
- Qualrep Services B.V. NL-AR-000000537
Sources (2)
- EUDAMED 6b418adf-381a-4000-9413-e5752f741e0e 61 fields · synced Jun 19, 2026
- FDA UDI 16d1b153-1e50-4368-a72b-780f3107e5dd 34 fields · synced May 30, 2026