Dash 6

Basic Information

• Brand Name: Dash 6
• Primary DI: 05060498307314
• Version / Model: 15161001
• Catalog Number: 15161001
• 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: 45fd8019-4310-45c1-9d4e-36ddab9b2a5f

Device Description

Dash 6, Ommaya Reservoir Kit, NRFit® Accessories, Single Use

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Safe
• Direct Marking Exempt: Yes
• 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: Yes
• 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
34845	Intrathecal anaesthesia set, non-medicated	A collection of devices intended for the administration of an analgesic or anaesthetic agent (not included) to the intrathecal space for the management of pain (known as spinal block, subarachnoid block, or intradural block). It includes a spinal needle and a syringe, with additional devices utilized for the procedure (e.g., dressings). It is not intended for epidural anaesthesia. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	05060498307338	GS1	Case	8	Not in Commercial Distribution	2020-07-21
Package	05060498307321	GS1	Box	5	Not in Commercial Distribution	2023-03-21
Primary	05060498307314	GS1