FDA.reportPublic FDA data

MDHC

Primary DI
06974669350339
Brand
MDHC
Company
MDHC Life Technologies (Kunshan) Co., LTD.
Model
12 pcs/Case
Device description
Filtration Systems
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KETFilters, Cell Collection, Tissue Processing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KETFilters, Cell Collection, Tissue ProcessingPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974669350339PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974669350339069746693503396974669350339

GMDN Terms#

Term, Definition table
TermDefinition
Sperm filtration systemAn assembly of devices incorporating filters that separate motile sperm from nonmotile sperm and seminal fluid/plasma for use in intrauterine insemination and other forms of assisted reproduction techniques. In some systems, the semen is filtered through a mechanical matrix filter. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
625685749
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974669350292MDHC20 pcs/bag2023-07-06
06974669350193MDHC5 pcs2023-07-06
06974669350209MDHC1 pair2023-07-06
06974669350216MDHC1 pcs2023-07-06
06974669350223MDHC10 pcs2023-07-06
06974669350230MDHC1 pcs/box2023-07-06
06974669350247MDHC5 units/case2023-07-06
06974669350254MDHC250 tips/box2023-07-06
06974669350261MDHC5 pcs/bag2023-07-06
06974669350278MDHC10 pcs/box2023-07-06
06974669350285MDHC5 pcs/bag2023-07-06
06974669350308MDHC1 pcs/bag2023-07-06
06974669350315MDHC6 pcs/box2023-07-06
06974669350322MDHC5 pcs/bag2023-07-06
06974669350346MDHC50 serving/box2023-07-06
06974669350353MDHC1 set/bag2023-07-06
06974669350360MDHC1 set/bag2023-07-06
06974669350377MDHC5 pcs/bag2023-07-06
06974669350384MDHC5 pcs/bag2023-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09551020410078PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410085PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410313PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410504PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
09551020410511PathTezt®BIOCYTECH CORPORATION SDN. BHD.KET2026-03-11
04260649292075cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292099cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292112cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292068cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292082cytoQ®SABEU GmbH & Co. KGKET2026-02-10
04260649292105cytoQ®SABEU GmbH & Co. KGKET2026-02-10
07898027900792CELLPRESERV KOLPLASTKolplast C IKET2023-11-29
00630094188508Bioseal Inc.BIOSEALKET2023-10-05
00630094188515Bioseal Inc.BIOSEALKET2023-10-05
00630094188607Bioseal Inc.BIOSEALKET2023-10-05
00630094887029Bioseal Inc.BIOSEALKET2023-10-05
00630094889054Bioseal Inc.BIOSEALKET2023-10-05
10630094188505Bioseal Inc.BIOSEALKET2023-10-05
10630094188512Bioseal Inc.BIOSEALKET2023-10-05
10630094188604Bioseal Inc.BIOSEALKET2023-10-05
10630094887026Bioseal Inc.BIOSEALKET2023-10-05
10630094889051Bioseal Inc.BIOSEALKET2023-10-05
00853778007005Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
00853778007135BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
00853778007142Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
00853778007159BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21
20853778007009Double Cytology Funnel w/ White Card and CapsBiomedical Polymers, Inc.KET2023-08-21
10853778007132BMP Medical Single Cytology Funnel w/ White CardBiomedical Polymers, Inc.KET2023-08-21
10853778007149Single Cytology Funnel w/ Brown CardBiomedical Polymers, Inc.KET2023-08-21
10853778007156BMP Medical Metal Cytology ClipBiomedical Polymers, Inc.KET2023-08-21