FDA UDI
In Commercial Distribution
🇺🇸 United States
Dash 6
DI: 05060498301442
·
Model: 15111001
·
INTERVENE GROUP LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Dash 6
- Primary DI
- 05060498301442
- Version / Model
- 15111001
- Catalog Number
- 15111001
- Company Name
- INTERVENE GROUP LIMITED
- Labeler DUNS
- 735285129
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-22
- Public Version
- 1
- Public Version Date
- 2024-01-30
- Public Version Status
- New
- Public Device Record Key
- 9ba3cb48-6f9c-4f1b-a083-d5387ac8fbbe
Device Description
Dash 6, Needle Hub Cap, NRFit® Accessories, Single Use 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 |
|---|---|---|---|---|
| BSN | FILTER, CONDUCTION, ANESTHETIC | Anesthesiology | 868.5130 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65011 | NRFit-formatted protective cap | A small, noninvasive, closed-ended, NRFit-formatted (ISO 80369-6) attachment intended to be attached to a neuraxial device (e.g., epidural catheter, neuraxial filter or syringe) with an NRFit connection to close the device lumen, typically to prevent fluid path contamination and/or spillage; it is not intended to disinfect/maintain disinfection. It is typically made of synthetic polymers and may incorporate a strap; it does not incorporate a filter or valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05060498301459 | GS1 | Box | 100 | In Commercial Distribution | |
| Primary | 05060498301442 | GS1 | ||||
| Package | 05060498301466 | GS1 | Case | 8 | In Commercial Distribution |