FDA UDI
In Commercial Distribution
🇺🇸 United States
G-Jet® Transgastric-Jejunal Feeding Device
DI: 00842071131371
·
Model: GJ-1670-45-I
·
APPLIED MEDICAL TECHNOLOGY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- G-Jet® Transgastric-Jejunal Feeding Device
- Primary DI
- 00842071131371
- Version / Model
- GJ-1670-45-I
- Catalog Number
- GJ-1670-45-I
- Company Name
- APPLIED MEDICAL TECHNOLOGY, INC.
- Labeler DUNS
- 038101861
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-03-14
- Public Version
- 2
- Public Version Date
- 2022-04-08
- Public Version Status
- Update
- Public Device Record Key
- 2e6867ce-a305-4202-abae-51a30f0a7afe
Device Description
16FR x 7.0 cm x 45 cm Low Profile Transgastric-Jejunal Feeding Device (ENFit®)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- MR Conditional
- 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 |
|---|---|---|---|---|
| 47656 | Gastrojejunostomy tube | A thin, flexible, hollow tube intended to be percutaneously inserted into the stomach, typically through puncture of the abdominal wall and stomach after distention of the stomach by endoscopic methods, with an extended portion inserted through the pylorus into the jejunum, to feed a patient who has a physical disability that prevents oral feeding (e.g., a birth defect or a neuromuscular condition) and/or to provide drainage/decompression for an obstructed stomach; it may also be used to administer medication to a patient. Additional invasive devices used to assist gastrostomy and tube introduction (e.g., guidewire) may be included with the tube. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842071131371 | GS1 |
Customer Contacts
- Phone
- (440)717-4000
- [email protected]
Premarket Submissions
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 7.0 | Centimeter | |
| Catheter Gauge | 16 | French | |
| Length | 45 | Centimeter |