FDA UDI
In Commercial Distribution
🇺🇸 United States
Valstar
DI: 00367979001002
·
Model: N/A
·
ENDO PHARMACEUTICALS INC.
Product Codes
0
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Valstar
- Primary DI
- 00367979001002
- Version / Model
- N/A
- Company Name
- ENDO PHARMACEUTICALS INC.
- Labeler DUNS
- 178074951
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-06-05
- Public Version
- 1
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- a621637c-c67d-40be-8477-cc24a2030bc7
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63177 | Urethral catheterization support kit, intravesical chemotherapy | A collection of various sterile, non-surgical devices dedicated to supporting the intravesical (in the bladder) administration of a chemotherapeutic pharmaceutical agent (not included) typically for the treatment of bladder cancer. It may include tubing, a saline bag filled with saline, and a saline bag spike; the urethral catheter is not included. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00367979001002 | GS1 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 20 – 25 Degrees Celsius