FDA UDI
In Commercial Distribution
🇺🇸 United States
Gabriel 3-way EnFit Valve
DI: 00860000931366
·
Model: GEV-0001
·
SYNCRO MEDICAL INNOVATIONS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Gabriel 3-way EnFit Valve
- Primary DI
- 00860000931366
- Version / Model
- GEV-0001
- Catalog Number
- GEV-0001
- Company Name
- SYNCRO MEDICAL INNOVATIONS
- Labeler DUNS
- 001058887
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-07
- Public Version
- 1
- Public Version Date
- 2021-02-15
- Public Version Status
- New
- Public Device Record Key
- 0a41ccf4-1fc5-4df0-89e8-740dd34f03df
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| PIF | Gastrointestinal Tubes With Enteral Specific Connectors | Gastroenterology, Urology | 876.5980 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64700 | ENFit/non-ISO80369-standardized small-bore multichannel connector | A small, non-powered, noninvasive, small-bore, tubular connector with three or more connections, which includes both an ENFit connection(s) [designed according to ISO 80369-3 for enteral applications] and a connection(s) which is not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases), designed to connect an enteral device(s) [e.g., enteral syringe, feeding tube, administration set] with an ENFit connection(s) typically to tubing or a syringe. It does not have a Luer or ENLock connection(s), and 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 |
|---|---|---|---|---|---|---|
| Primary | 00860000931366 | GS1 |
Customer Contacts
- Phone
- (888)980-9159
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K201741 | 000 |