FDA.reportPublic FDA data

MDHC

Primary DI
06974669350308
Brand
MDHC
Company
MDHC Life Technologies (Kunshan) Co., LTD.
Model
1 pcs/bag
Device description
Transfer pipette
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GJGPipette, Quantitative, Hematology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJGPipette, Quantitative, HematologyHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974669350308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974669350308069746693503086974669350308

GMDN Terms#

Term, Definition table
TermDefinition
Pipette tip IVDA device formed as a pointed cylindrical tip that is attached to the dispensing opening of a pipette, or a dispenser, and where the required volume of liquid (e.g., reagent, buffer, biological specimen) is drawn for delivery to a target receptacle during an in vitro diagnostic procedure. It is typically used for manual procedures or onboard automated liquid handling instruments or analysers. 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
06974669350315MDHC6 pcs/box2023-07-06
06974669350322MDHC5 pcs/bag2023-07-06
06974669350339MDHC12 pcs/Case2023-07-06
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
M52536110H-Pette without Blade (1000 pieces)HELENA LABORATORIES CORPORATIONGJG2017-05-26
M52536120H-Pette with Blade (1000 pieces)HELENA LABORATORIES CORPORATIONGJG2017-05-26
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)HELENA LABORATORIES CORPORATIONGJG2017-05-26