FDA UDI
In Commercial Distribution
🇺🇸 United States
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
DI: 00827002447844
·
Model: SBRD-20-ENF
·
XERIDIEM MEDICAL DEVICES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection
- Primary DI
- 00827002447844
- Version / Model
- SBRD-20-ENF
- Catalog Number
- 70-0060-220
- Company Name
- XERIDIEM MEDICAL DEVICES, INC.
- Labeler DUNS
- 183325125
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-01
- Public Version
- 5
- Public Version Date
- 2020-04-20
- Public Version Status
- Update
- Public Device Record Key
- 78aae10d-925e-411b-810d-f320a989993a
Device Description
Entuit Gastrostomy BR Balloon Retention Feeding Tube with ENFit Connection, 20 FR
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
- No
- 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 |
|---|---|---|---|---|
| 35419 | Gastrostomy tube | A thin, flexible, percutaneous, hollow tube which may include additional external components (e.g., external tubing, syringe) intended to be percutaneously inserted into the stomach to feed a patient with a physical disability that prevents oral feeding (e.g., a birth defect of the stomach), and/or provide drainage/decompression of the stomach when it is necessary to bypass an obstruction of the stomach outlet into the small intestine. Although noninvasive disposable enteral feeding components may be included, surgical instruments and pharmaceutical agents are not included. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10827002447841 | GS1 | Case Box | 10 | In Commercial Distribution | |
| Primary | 00827002447844 | GS1 |
Customer Contacts
- Phone
- (520) 882-7794
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K130611 | 000 |