FDA UDI
In Commercial Distribution
🇺🇸 United States
VYGON
DI: 03660812130332
·
Model: 881.11
·
VYGON
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- VYGON
- Primary DI
- 03660812130332
- Version / Model
- 881.11
- Catalog Number
- 00088111
- Company Name
- VYGON
- Labeler DUNS
- 392994778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-21
- Public Version
- 1
- Public Version Date
- 2021-06-29
- Public Version Status
- New
- Public Device Record Key
- 7b4d0541-b36f-4755-970e-e535c3915f89
Device Description
Vyconnector - Straight double taper connector and adaptor - ØExt. 10.0-13.0mm / 10.0-13.0mm
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
- Yes
- 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 |
|---|---|---|---|---|
| BZA | CONNECTOR, AIRWAY (EXTENSION) | Anesthesiology | 868.5810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 64466 | Non-ISO80369-standardized small-bore linear connector, single-use | A small, non-powered, noninvasive, small-bore, tubular, two-way/linear connector with connections at each end (typically barbed, bayonet, conical, threaded and/or non-Luer-slip) which are not designed according to ISO 80369 (standard for small-bore connectors for liquids and gases) intended to connect two luminal devices (e.g., catheter, tubing, container) with each other. It may have a straight or elbow shape; it does not have a Luer connection(s) (neither lock nor slip), and does not incorporate a filter, valve, clamp, tubing nor puncturing component, and is not a dedicated gas-line connector. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 33660812130333 | GS1 | Box | 30 | In Commercial Distribution | |
| Primary | 03660812130332 | GS1 | ||||
| Package | 53660812130337 | GS1 | Case | 48 | In Commercial Distribution |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius