Marathon
by Medline Industries, LP United States EUDAMEDGUDID
Ref MSC093001
Product code KMFEMDN A108004
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number0884389DC281NSJP | Date6 Mar 2026 | StatusActive |
| United States | GUDID listing GUDID | Number30884389109858 | Date19 May 2021 | StatusIn distribution |
Coverage
- Active
- Listed
- Not covered
- European Union
- United States
Specification
- Trade Name
- Marathon EUDAMEDMedline Industries, Inc. GUDID
- Generic Name
- Skin-cover sealant
- Device Name
- Skin Protectant
- Model / Ref / Catalog
- MSC093001
- Primary DI / UDI-DI
- 30884389109858 EUDAMED10884389109854 GUDID
- Basic UDI-DI
- 0884389DC281NSJP
- Unit of Use DI
- 00884389109857
- 510(k) Number
- FDA Product Code
- KMF
- EMDN Code
- A108004 Protective films / sprays for peristomal skin
- GMDN Term
- Skin-cover sealant
- Device Class
- Class I
- Regulation Number
- 880.5090
- Market of Registration
- Netherlands
- Commercial Distribution
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Primary DI / UDI-DI | 30884389109858 | 10884389109854 |
Manufacturer details
- EUDAMED SRN
- US-MF-000009717
- Authorised representative
- Medline International France FR-AR-000001814
Other devices from Medline Industries, Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (19)
- Sterile: No
- 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
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Premarket Exempt: No
- Serial Number: No
Sources (2)
- EUDAMED 21774689-7080-4f24-a296-dc07c284acbf
- FDA UDI 2e0170ac-de5b-4897-9212-c339b081b079