FDA UDI
In Commercial Distribution
🇺🇸 United States
SCANLAN® Special Orders
DI: 00846159023930
·
Model: 1001-09
·
SCANLAN INTERNATIONAL INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- SCANLAN® Special Orders
- Primary DI
- 00846159023930
- Version / Model
- 1001-09
- Catalog Number
- 1001-09
- Company Name
- SCANLAN INTERNATIONAL INC
- Labeler DUNS
- 023055619
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-11
- Public Version
- 1
- Public Version Date
- 2019-01-11
- Public Version Status
- New
- Public Device Record Key
- 6e4dff42-c21b-4a50-aa51-4cc6c46a43a8
Device Description
Heparin Flushing Needle 18G-2"TDIA
Device Characteristics
- Single Use
- No
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GDM | Needle, Aspiration And Injection, Reusable | General, Plastic Surgery | 878.4800 | 1 |
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 |
|---|---|---|---|---|---|---|
| Primary | 00846159023930 | GS1 |
Customer Contacts
- Phone
- 651-297-0997
- [email protected]