FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Stradis Medical, LLC.
DI: M75268220251
·
Model: 682-2025
·
STRADIS MEDICAL, LLC
Product Codes
0
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Stradis Medical, LLC.
- Primary DI
- M75268220251
- Version / Model
- 682-2025
- Company Name
- STRADIS MEDICAL, LLC
- Labeler DUNS
- 174262477
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-29
- Public Version
- 2
- Public Version Date
- 2023-02-10
- Public Version Status
- Update
- Public Device Record Key
- 004259f4-b970-4c4f-98a8-01c5ef9f6730
- Distribution End Date
- 2023-02-09
Device Description
5mL Syringes, Sterile Solution
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- 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
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62339 | Catheter flush syringe connector | A sterile tubular device intended to connect to a syringe to channel a solution (e.g., sterile water) from the syringe into the proximal end of a catheter during catheter flushing. It contains a noncoring needle designed to be inserted into the catheter lumen for injection of the flushing solution. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | M7526822025 | HIBCC | outer box | 100 | Not in Commercial Distribution | 2023-02-09 |
| Primary | M75268220251 | HIBCC |
Customer Contacts
- Phone
- 1-800-424-8520
- [email protected]