FDA UDI
In Commercial Distribution
🇺🇸 United States
VYGON
DI: 03660812008341
·
Model: 669.10
·
VYGON
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- VYGON
- Primary DI
- 03660812008341
- Version / Model
- 669.10
- Catalog Number
- 00066910
- Company Name
- VYGON
- Labeler DUNS
- 392994778
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-06-09
- Public Version
- 1
- Public Version Date
- 2021-06-17
- Public Version Status
- New
- Public Device Record Key
- 4e35a103-de96-4a97-91e3-805a4f7ddfd6
Device Description
Single valve for thoracic drainage (Heimlich type)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- Yes
- 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 |
|---|---|---|---|---|
| KDD | Kit, surgical instrument, disposable | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62752 | Pleural drainage valve | A sterile, noninvasive device in the form of a small polymer housing intended to be connected to a pleural catheter to prevent backflow of gas into the pleural cavity during drainage of fluid and gas from the pleural cavity. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 53660812008346 | GS1 | Case | 6 | In Commercial Distribution | |
| Package | 33660812008342 | GS1 | Box | 25 | In Commercial Distribution | |
| Primary | 03660812008341 | GS1 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 5 – 40 Degrees Celsius