FDA.reportPublic FDA data

Dash 6

Primary DI
05060498302104
Brand
Dash 6
Company
INTERVENE GROUP LIMITED
Model
15110001
Catalog number
15110001
Device description
Dash 6, Needle Hub Cap, NRFit® Accessories, Single Use
Published
2024-01-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
BSNFILTER, CONDUCTION, ANESTHETIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
BSNFilter, Conduction, AnestheticAnesthesiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060498302104PackageGS11000In Commercial Distribution
05060498302111PackageGS110In Commercial Distribution
05060498306980PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060498302104050604983021045060498302104
05060498302111050604983021115060498302111
05060498306980050604983069805060498306980

GMDN Terms#

Term, Definition table
TermDefinition
NRFit-formatted protective capA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
735285129
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060498301565Dash 615231022152310222024-01-22
05060498301688Dash 615311022153110222024-01-22
05060498306881Dash 615310022153100222024-01-22
05060498301022Dash 615011010150110102023-06-02
05060498301053Dash 615011030150110302023-06-02
05060498301084Dash 615011050150110502023-06-02
05060498301114Dash 615011100150111002023-06-02
05060498301145Dash 615011200150112002023-06-02
05060498301176Dash 615011600150116002023-06-02
05060498301206Dash 615021010150210102023-06-02
05060498301237Dash 615021030150210302023-06-02
05060498301268Dash 615021050150210502023-06-02
05060498301329Dash 615021100150211002023-06-02
05060498301381Dash 615021200150212002023-06-02
05060498307017Dash 615020200150202002023-06-02
05060498307031Dash 615020100150201002023-06-02
05060498307055Dash 615020050150200502023-06-02
05060498307062Dash 615020030150200302023-06-02
05060498307079Dash 615020010150200102023-06-02
05060498307086Dash 615010600150106002023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048223120316FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223120323FilterPajunk GmbH MedizintechnologieBSN2025-04-04
04048223069585MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
04048223048993MiniFilter 0,2µmPajunk GmbH MedizintechnologieBSN2025-01-30
00840178703477ITDTouchpoint Medical, Inc.BSN2024-09-16
05060498301411Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301442Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301565Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301688Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306881Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306904Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306980Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301435Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301459Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301572Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498301695Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302289Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498302265Dash 6INTERVENE GROUP LIMITEDBSN2024-01-22
05060498306911Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
05060498302227Dash 6INTERVENE GROUP LIMITEDBSN2023-06-02
04048223049877FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
04048223050064FILTERPajunk GmbH MedizintechnologieBSN2021-04-02
14048223031312NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
14048223041793Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223031315NiniFilter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
04048223041796Filter NRFitPajunk GmbH MedizintechnologieBSN2020-07-22
15019315107283PortexICU MEDICAL, INC.BSN2020-06-22
35019315107287PortexSmiths Medical Czech Republic a.s.BSN2020-06-22
15019517054651PortexICU MEDICAL, INC.BSN2020-03-09
15019517071368PortexICU MEDICAL, INC.BSN2020-03-09