FDA.reportPublic FDA data

Dash 6

Primary DI
05060498301022
Brand
Dash 6
Company
GBUK GROUP LIMITED
Model
15011010
Catalog number
15011010
Device description
Dash 6, Lock Syringes, NRFit® Syringes, Single Use 1ml
Published
2023-06-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060498301039PackageGS1100Not in Commercial Distribution
05060498301046PackageGS110Not in Commercial Distribution
05060498301022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060498301039050604983010395060498301039
05060498301046050604983010465060498301046
05060498301022050604983010225060498301022

GMDN Terms#

Term, Definition table
TermDefinition
Neuraxial syringeA sterile device consisting of a calibrated barrel (cylinder) with plunger intended for neuraxial applications (to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes). At the distal end of the barrel is a male connector, designed according to ISO 80369-6 (often referred to as an NRFit connection), intended specifically for connection to neuraxial devices (e.g., needles, catheters, tubing) with the appropriate NRFit connection. This is a single-use device.

Regulatory Flags#

DUNS number
220705343
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
10850002550006EnteralVED-691VED-6912022-11-01
10850002550013EnteralVED-692VED-6922022-11-01
10850002550020EnteralVED-693VED-6932022-11-01
10850002550037EnteralVED-694VED-6942022-11-01
10850801006995EnteralVED-690VED-6902022-11-01
00850801006967EnteralVED-670VED-6702022-10-20
05056038302895TenderTipTT02-05-E31TT02-05-E312023-06-02
05056038302925TenderTipTT02-06-E31TT02-06-E312023-06-02
05056038302956TenderTipTT02-06-P31TT02-06-P312023-06-02
05056038302987TenderTipTT02-07-P31TT02-07-P312023-06-02
05056038303014TenderTipTT02-08-E31TT02-08-E312023-06-02
05056038303045TenderTipTT02-08-P31TT02-08-P312023-06-02
05056038303083TenderTipTT02-10-E54-NTT02-10-E54-N2023-06-02
05056038303137TenderTipTT02-12-E54-NTT02-12-E54-N2023-06-02
05056038303175TenderTipTT02-12-T34-NTT02-12-T34-N2023-06-02
05056038303212TenderTipTT02-14-E54-NTT02-14-E54-N2023-06-02
05056038303250TenderTipTT02-14-T34-NTT02-14-T34-N2023-06-02
05056038303298TenderTipTT03-12-E54-NTT03-12-E54-N2023-06-02
05056038303335TenderTipTT03-12-T34-NTT03-12-T34-N2023-06-02
05056038303373TenderTipTT03-14-E54-NTT03-14-E54-N2023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800045103061Feel Ject(FIS-054, U-100, 1.0cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105164Feel Ject(FIS-202, U-100, 0.3 cc, 29G x 12.7mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105256Feel Ject(FIS-205, U-100, 0.3 cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105492Feel Ject(FIS-213, U-100, 1.0cc, 31G x 8mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
08800045105614Feel Ject(FIS-217, U-100, 0.5 cc, 31G x 6mm)Feel Tech Bio Co., Ltd.FMF2026-07-29
00810131885045ION Non CervicalSurgentec, LLCFMF2026-07-28
00884450486955Merit Medical®Merit Medical Systems, Inc.FMF2026-07-25
10816336022275NC600300-ENFNEOCHILD, LLCFMF2026-07-23
10816336022282NC602000-ENFNEOCHILD, LLCFMF2026-07-23
10816336022442NC600100-ENFNEOCHILD, LLCFMF2026-07-23
00884450492888Merit Medical®Merit Medical Systems, Inc.FMF2026-07-22
10383017593015Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593213Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593411Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593510Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017593718Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844612Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844711Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
10383017844919Ultra-Fine SAFETYEmbecta Medical II, LLCFMF2026-07-21
18257200121076O-GENESISOrthofix US LLCFMF2026-07-17
18257200121083O-GENESISOrthofix US LLCFMF2026-07-17
05391530753944Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753951Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754217Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754620Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754699Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754941NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530754965NuGen syringeDMC MEDICAL LIMITEDFMF2026-06-03
05391530753968Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02
05391530754088Polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-06-02