FDA UDI
In Commercial Distribution
🇺🇸 United States
EndoVive Y-Port Feeding Adapter
DI: 08714729751236
·
Model: M00580640
·
BOSTON SCIENTIFIC CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- EndoVive Y-Port Feeding Adapter
- Primary DI
- 08714729751236
- Version / Model
- M00580640
- Company Name
- BOSTON SCIENTIFIC CORPORATION
- Labeler DUNS
- 021717889
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2020-09-30
- Public Version Status
- Update
- Public Device Record Key
- 4b76a6bf-ff28-4823-8853-45c9951e963b
Device Description
Initial Gastrostomy Tube Y-Port Adapter
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
- 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
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 |
|---|---|---|---|---|
| 64697 | Luer/non-ISO80369-standardized small-bore multichannel connector | A small, non-powered, noninvasive, small-bore, tubular connector with three or more connections, which includes both a Luer connection(s) and a connection(s) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), designed to connect three or more luminal devices (e.g., catheter, tubing, container) with each other. It does not incorporate a filter, valve, clamp, tubing nor puncturing component. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08714729169116 | GS1 | 10 | In Commercial Distribution | ||
| Primary | 08714729751236 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 20 F Diameter | ||
| Device Size Text, specify | 6.7 mm Diameter |