Identity
- Trade Name
- Marcon FDA UDI
- Generic Name
- Colonic decompression tube FDA UDI
- Device Name
- Marcon Colon Decompression Set FDA UDI
- Model / Reference
- G21938 FDA UDI
- Description
- Marcon Colon Decompression Set FDA UDI
Identifiers
- Catalog Number
- CDSM-7 FDA UDI
- Primary DI / UDI-DI
- 00827002219380 FDA UDI
- FDA Product Code
- FEG FDA UDI
- GMDN Term
- Colonic decompression tube FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
MR Safe FDA UDI
Category: Colonic decompression tube
Marcon by Cook Ireland, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Colonic decompression tube.
- Cook — Cook Ireland, Ltd. · Class II
- Marcon — Cook Ireland, Ltd. · Class II
- Marcon — Cook Ireland, Ltd. · Class II
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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cook Ireland, Ltd.
Sources (1)
- FDA UDI e859dd8a-cff2-4eb0-a420-a6f19b18399d 36 fields · synced May 30, 2026