FDA UDI
In Commercial Distribution
🇺🇸 United States
Dash 6
DI: 05060498307055
·
Model: 15020050
·
INTERVENE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dash 6
- Primary DI
- 05060498307055
- Version / Model
- 15020050
- Catalog Number
- 15020050
- Company Name
- INTERVENE GROUP LIMITED
- Labeler DUNS
- 735285129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-06-02
- Public Version
- 1
- Public Version Date
- 2023-06-12
- Public Version Status
- New
- Public Device Record Key
- 49e5998b-7f16-46c8-a349-e2472542b7cc
Device Description
Dash 6, Slip Syringes, NRFit® Syringes, Single Use 5ml (BNS)
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- 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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FMF | Syringe, piston | General Hospital | 880.5860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63603 | Neuraxial syringe | A sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications (to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes). At the distal end of the barrel is a male connector, designed according to ISO 80369-6 (often referred to as an NRFit connection), intended specifically for connection to neuraxial devices (e.g., needles, catheters, tubing) with the appropriate NRFit connection. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060498301978 | GS1 | Case | 1 | In Commercial Distribution | |
| Package | 05060498301961 | GS1 | Peel Pack | 500 | In Commercial Distribution | |
| Primary | 05060498307055 | GS1 |