FDA.reportPublic FDA data

BAIXIN

Primary DI
06936018500376
Brand
BAIXIN
Company
Anhui Kangda Medical Products Co.,Ltd.
Model
5MLLL
Published
2021-06-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083686000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083686000BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZESAnhui Kangda Medical Products Co., Ltd.2009-07-02FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06936018500383PackageGS1800In Commercial Distribution
06936018500376PrimaryGS10
06936018500369Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06936018500383069360185003836936018500383
06936018500376069360185003766936018500376
06936018500369069360185003696936018500369

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
529827552
Device count
100
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936018502424baixinKD2222025-11-19
06936018502219baixin27GDN2025-05-28
06936018502240baixin30GDN2025-05-28
06936018502202baixin27GDN2025-05-28
06936018502257baixin30GDN2025-05-28
06936018501618BAIXIN18GSVS2024-03-04
06936018501649BAIXIN19GSVS2024-03-04
06936018501670BAIXIN20GSVS2024-03-04
06936018501700BAIXIN21GSVS2024-03-04
06936018501731BAIXIN22GSVS2024-03-04
06936018501762BAIXIN23GSVS2024-03-04
06936018501793BAIXIN24GSVS2024-03-04
06936018501823BAIXIN25GSVS2024-03-04
06936018501854BAIXIN26GSVS2024-03-04
06936018501885BAIXIN27GSVS2024-03-04
06936018501625BAIXIN18GSVS2024-03-04
06936018501656BAIXIN19GSVS2024-03-04
06936018501687BAIXIN20GSVS2024-03-04
06936018501717BAIXIN21GSVS2024-03-04
06936018501748BAIXIN22GSVS2024-03-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05391530754033Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754057Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754118Polycarbonate SyringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754149polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754170polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754255polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754279polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754286polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754323polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754385polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754415polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754477polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754484polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
05391530754651polycarbonate syringesDMC MEDICAL LIMITEDFMF2026-09-27
05391530754736polycarbonate syringeDMC MEDICAL LIMITEDFMF2026-09-27
10192253070804MonojectCardinal Health 200, LLCFMF2026-09-21
M992MTINS01291271MedThermalCarelife (usa) Inc.FMF2026-09-18
M992MTINS0331081MedThermalCarelife (usa) Inc.FMF2026-09-18
00850091070242CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070372CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070389CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070396CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070402CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070419CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070426CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
00850091070433CoreCareCORECARE PRODUCTS INC.FMF2026-09-04
06976523540238Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540245Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
06976523540252Sterile Insulin Syringes with needles for single useShandong Caremed Medical Products Co.,LtdFMF2026-08-26
00193982458119INSTAFILLGLOBUS MEDICAL, INC.FMF2026-08-14