FDA UDI
In Commercial Distribution
🇺🇸 United States
Replaceable Inner Tubes
DI: 07290018632147
·
Model: FG-20F-GREEN-REP
·
FIDMI MEDICAL LTD
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Replaceable Inner Tubes
- Primary DI
- 07290018632147
- Version / Model
- FG-20F-GREEN-REP
- Catalog Number
- FG-20F-GREEN-REP
- Company Name
- FIDMI MEDICAL LTD
- Labeler DUNS
- 600363369
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2021-08-15
- Public Version
- 1
- Public Version Date
- 2021-08-23
- Public Version Status
- New
- Public Device Record Key
- 66f7cceb-7c73-4796-b022-4366e527419f
Device Description
The Replacement Feeding Tube is designed to be replaced when needed. It is attached to the placed PEG device as it is slid into its location within the tube resulting in its distal end to reach the distal end of the main tube and internal bumper thus allowing the required substances (food or medications) to be inserted directly into the stomach.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62495 | Enteral tube extension, non-sterile | A non-sterile, thin, flexible tube intended for extracorporeal connection to an enteral feeding tube (e.g., nasogastric tube) to increase the length of tubing from the patient to an oral/enteral device (e.g., syringe) during enteral feeding/medication administration or aspiration. It is typically a single-lumen, rubber or plastic tube of various diameters/lengths. This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 17290018632144 | GS1 | ||||
| Primary | 07290018632147 | GS1 |