DORA

Primary DI
16948082749688
Brand
DORA
Company
Bain Medical Equipment (Guangzhou) Co., Ltd.
Model
BAIN-A.V.F-003SE
Published
2023-04-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FIENeedle, Fistula

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FIENeedle, FistulaGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16948082749688PackageGS150In Commercial Distribution
26948082749685PackageGS110In Commercial Distribution
06948082749681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694808274968816948082749688
2694808274968526948082749685
06948082749681069480827496816948082749681

GMDN Terms#

Term, Definition table
TermDefinition
Haemodialysis needleA sterile, sharp bevel-edged, hollow tubular metal instrument used to remove and return a patient's blood during a haemodialysis procedure. Commonly known as a dialysis needle. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
526972767
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06948082700729DORABAIN-BL-002E2026-05-13
06948082753947DORABAIN-A.V.F-001ASE2026-05-13
06948082753954DORABAIN-A.V.F-001VSE2026-05-13
06948082770036NovaLine9560072024-07-31
16948082770033NovaLine9560072024-07-31
06948082746086DORABAIN-A.V.F-001SE2023-04-11
06948082746093DORABAIN-A.V.F-005SE2023-04-11
06948082746116DORABAIN-A.V.F-049SE2023-04-11
06948082749681DORABAIN-A.V.F-003SE2023-04-11
06948082749698DORABAIN-A.V.F-007SE2023-04-11
06948082749704DORABAIN-A.V.F-051SE2023-04-11
16948082746083DORABAIN-A.V.F-001SE2023-04-11
16948082746090DORABAIN-A.V.F-005SE2023-04-11
06948082746109DORABAIN-A.V.F-009SE2023-04-11
16948082746113DORABAIN-A.V.F-049SE2023-04-11
16948082749695DORABAIN-A.V.F-007SE2023-04-11
16948082749701DORABAIN-A.V.F-051SE2023-04-11
06948082746642DORABAIN-A.V.F-011SE2022-12-28
06948082746659DORABAIN-A.V.F-012SE2022-12-28
06948082709777NovaLineBL 422022-01-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04711552764857SUNDERSUNDER BIOMEDICAL TECH. CO., LTD.FIE2026-04-24
00842289102743masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102750masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102767masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102774masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102781masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102798masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102804masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102811masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102828masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102835masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102842masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102859masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102866masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102873masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102880masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102897masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102903masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102910masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102927masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102934masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102941masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102958masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102965masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102972masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102989masterguard plus HEMODIALYSIS FISTULA NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-14
00842289102460ButtonHole SINGLE NEEDLE SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102590NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102644NxStage SINGLE NEEDLE FISTULA SETNXSTAGE MEDICAL, INC.FIE2020-07-06
00842289102668masterguard APHERESIS NEEDLENXSTAGE MEDICAL, INC.FIE2020-07-06