Identity
- Trade Name
- Low Profile Enteral Feeding Device Kit FDA UDI
- Generic Name
- Gastrostomy button FDA UDI
- Device Name
- The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement. FDA UDI
- Model / Reference
- FG-20F-BLUE FDA UDI
- Description
- The Fidmi Medical Low Profile Gastrostomy Device is a single use, sterile, disposable device, that allows for enteral nutriton and / or medicaton delivery directly into the stomach. The PEG placement kit is supplied with the components needed for device placement. FDA UDI
Identifiers
- Catalog Number
- FG-20F-BLUE FDA UDI
- Primary DI / UDI-DI
- 07290018632031 FDA UDI
- FDA Product Code
- KGC FDA UDI
- GMDN Term
- Gastrostomy button 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
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
No
FDA UDI
Category: Gastrostomy button
Low Profile Enteral Feeding Device Kit by Fidmi Medical, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Fidmi Medical, Ltd.
Sources (1)
- FDA UDI 6701d1c0-cb4d-4d26-b8a8-67e52915047b 34 fields · synced Jun 6, 2026