FDA UDI
In Commercial Distribution
🇺🇸 United States
Dash 6
DI: 05060498301657
·
Model: 15291050
·
INTERVENE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dash 6
- Primary DI
- 05060498301657
- Version / Model
- 15291050
- Catalog Number
- 15291050
- 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
- 99434326-8d2c-4589-a542-aa2cf11a12ad
Device Description
Dash 6, Blunt Drawing Up Needle With 5µm Filter, NRFit® Accessories, Single Use 18G x 50mm Sterile
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
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| BSP | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | Anesthesiology | 868.5150 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16266 | Medication transfer needle, filtering | A slender, rigid, sharp or blunt tube intended to be attached to a syringe and typically used in the pharmacy to aspirate and transfer fluid medication from a vial/ampule to another container for medication preparation or other purposes. It includes an integral filter (e.g., a microporous stainless steel filter) intended to retain micro-particles from the drug as it flows through the needle to reduce the risk of particle contamination of the patient medication; it does not include a back-pressure venting feature. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060498301671 | GS1 | Case | 8 | In Commercial Distribution | |
| Package | 05060498301664 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 05060498301657 | GS1 |