FDA.reportPublic FDA data

Dash 6

Primary DI
05060498302173
Brand
Dash 6
Company
INTERVENE GROUP LIMITED
Model
15200001
Catalog number
15200001
Device description
Dash 6, Epidural Catheter Feeder, NRFit® Accessories, Single Use
Published
2023-06-02
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
BSOCATHETER, CONDUCTION, ANESTHETIC

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060498302166PackageGS11000In Commercial Distribution
05060498302173PackageGS115In Commercial Distribution
05060498306959PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060498302166050604983021665060498302166
05060498302173050604983021735060498302173
05060498306959050604983069595060498306959

GMDN Terms#

Term, Definition table
TermDefinition
NRFit/epidural catheter linear connectorA small, non-powered, noninvasive, tubular device with an NRFit connection at one end (a connection designed specifically for neuraxial applications according to ISO 80369-6) and an epidural catheter adapting mechanism at the other end, intended to connect an external device with an NRFit connection (e.g., syringe) with an epidural catheter with no pre-existing connector. It is designed to connect over the epidural catheter and seal the connection with either an integrated clamping mechanism or by means of an adhesive port. It does not incorporate a valve, tubing nor puncturing component. 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
05060498301435Dash 615041001150410012024-01-22
05060498301459Dash 615111001151110012024-01-22
05060498301558Dash 615171001151710012024-01-22
05060498301572Dash 615231022152310222024-01-22
05060498301695Dash 615311022153110222024-01-22
05060498302289Dash 615310022153100222024-01-22
05060498302265Dash 615300001153000012024-01-22
05060498302104Dash 615110001151100012024-01-22
05060498302067Dash 615040001150400012024-01-22
05060498301039Dash 615011010150110102023-06-02
05060498301077Dash 615011030150110302023-06-02
05060498301091Dash 615011050150110502023-06-02
05060498301138Dash 615011100150111002023-06-02
05060498301152Dash 615011200150112002023-06-02
05060498301183Dash 615011600150116002023-06-02
05060498301213Dash 615021010150210102023-06-02
05060498301244Dash 615021030150210302023-06-02
05060498301275Dash 615021050150210502023-06-02
05060498301336Dash 615021100150211002023-06-02
05060498301398Dash 615021200150212002023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902221725ARROWTELEFLEX INCORPORATEDBSO2026-06-24
04048223070130InfiltraLong 420Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085066E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085073E-Cath® Plus NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223085554E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086087E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
04048223086261E-Cath® NRFit Tsui®Pajunk GmbH MedizintechnologieBSO2026-06-10
10801902155945ARROWTELEFLEX INCORPORATEDBSO2025-03-10
05060498301534Dash 6GBUK GROUP LIMITEDBSO2024-01-22
05060498306959Dash 6GBUK GROUP LIMITEDBSO2023-06-02
10801902189148ARROWTELEFLEX INCORPORATEDBSO2022-11-29
10801902197570ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902197730ARROWTELEFLEX INCORPORATEDBSO2022-11-09
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10801902207699ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207705ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207712ARROWTELEFLEX INCORPORATEDBSO2022-09-14
10801902207620ARROWTELEFLEX INCORPORATEDBSO2022-07-07
10801902207507ARROWTELEFLEX INCORPORATEDBSO2022-05-13