FDA UDI
In Commercial Distribution
🇺🇸 United States
Medela
DI: 00859950007061
·
Model: ENPU-20-65
·
FOOTPRINT MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Medela
- Primary DI
- 00859950007061
- Version / Model
- ENPU-20-65
- Company Name
- FOOTPRINT MEDICAL, INC.
- Labeler DUNS
- 791238046
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-09-05
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 7e2750b9-33fc-475d-893b-8ed2197da45a
Device Description
Polyurethane Enteral Feeding Tube - TwistLok - 20in by 6.5 French
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNT | Tubes, Gastrointestinal (And Accessories) | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 14221 | Nasogastric feeding tube | A sterile, thin, flexible, hollow cylinder intended to access the stomach of a patient through the nose and nasopharynx primarily for enteral feeding and the administration of medications, either by gravity or with a pump; it may also be used for aspiration of gastric contents (e.g., gastric secretions). It is typically a single lumen, rubber or plastic tube of various diameters (typically smaller than those of nasogastric tubes intended primarily for decompression) with circular markings that serve as insertion guides. It is frequently used for very ill or comatose patients. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10859950007068 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 00859950007061 | GS1 |
Customer Contacts
- Phone
- 8004358316
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K102548 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Catheter Gauge | 6.5 | French | |
| Length | 20 | Inch |