FDA.reportPublic FDA data

Bone Marrow Kit

Primary DI
M4454505K1
Brand
Bone Marrow Kit
Company
MEDICAL CHEMICAL CORPORATION
Model
4505K
Catalog number
4505K
Device description
A kit for collection and transport of bone marrow specimens.
Published
2020-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JKATubes, Vials, Systems, Serum Separators, Blood Collection
KDTContainer, Specimen Mailer And Storage, Sterile
KEWSlides, Microscope
NNIContainer, Specimen, Non-Sterile

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2
KDTContainer, Specimen Mailer And Storage, SterilePathology1
KEWSlides, MicroscopePathology1
NNIContainer, Specimen, Non-SterilePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M4454505K1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, K2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant dipotassium ethylene diamine tetraacetic acid (K2EDTA). It is intended to be used for the collection, and preservation and/or transport, of blood for analysis and/or other investigation [e.g., blood lead, whole blood haematology such as complete blood count (CBC), molecular diagnostics, and immunohaematology testing (ABO grouping, Rh typing, antibody screening)]. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008496861
Device count
1
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M445890151O&P Collection Vials C&S/Clean Kits890-15890-152020-08-31
M445891051O&P Collection Vials SAF / Clean/ C&S Kits891-05891-052020-08-31
M445891101Unifix / Clean / C&S Kits O&P Collection Vials891-10891-102020-08-31
M445891171Total-Fix / C&S / Clean O&P Collection Kits891-17891-172020-08-31
M44589117ORNGE1Total-Fix / C&S / Clean O&P Collection Kits891-17_ORNGE891-17_ORNGE2020-08-31
M445891201Formalin / C&S / Clean Stool Collection Kits891-20891-202020-08-31
M445892021Total-Fix / Formalin / C&S / Clean O&P Collection Kits892-02892-022020-08-31
M445892031Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445892030Z-PVA / Formalin / C&S / Clean O&P Collection Kits892-03892-032020-08-31
M445891081O&P Collection Vials Zinc-PVA / SAF / C&S Stool Collection Kit891-08891-082020-08-31
M445693A50PACK1SED-CONNECT693A 50 PACK693A 50 PACK2016-09-20
M445693AESEDEA50PACK1SED-CONNECT693A-E SED+EA693A-E SED+EA2016-09-20
M445693AFUNNEL1SED-CONNECT693A-FUNNEL693A-FUNNEL2016-09-20
M445693ASAMPLE1SED-CONNECT693A-Sample693A-Sample2016-09-20
M445694A1MICRO-SED694A694A2016-09-20
M445694AEA1MICRO-SED694A-EA694A-EA2016-09-20
M445694ASAMPLE1MICRO-SED694A-Sample694A-Sample2016-09-20
M445694ATUBEFUNNEL1MICRO-SED694A-TUBE/FUNNEL 1000694A-TUBE/FUNNEL 10002016-09-20
M445695A1PARA-SED695A695A2016-09-20
M445695AEA1PARA-SED695A-EA695A-EA2016-09-20

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Primary DI, Brand, Company table
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