FDA.reportPublic FDA data

CellSave

Primary DI
10888385000030
Brand
CellSave
Company
MENARINI SILICON BIOSYSTEMS, INC.
Model
952820
Catalog number
952820
Device description
Preservative Tube 20 pack
Published
2016-09-22
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
JKATubes, vials, systems, serum separators, blood collection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JKATubes, Vials, Systems, Serum Separators, Blood CollectionClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888385000030PrimaryGS10
80888385000039Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088838500003010888385000030
8088838500003980888385000039

GMDN Terms#

Term, Definition table
TermDefinition
Evacuated blood collection tube IVD, Na2EDTAA sterile glass or plastic tube, sealed with a stopper, containing a pre-measured amount of vacuum and the anticoagulant disodium ethylene diamine tetraacetic acid (Na2EDTA). 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 trace-element, toxicology, and nutritional-chemistry determinations). This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not use if the additive is not clear and colorless
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+1(877)837-4339xx@xx.xx

Regulatory Flags#

DUNS number
057722858
Device count
20
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888385000061CELLTRACKS AUTOPREP954195412016-09-22
10888385000078CELLTRACKS AUTOPREP790100379010032016-09-22
10888385000610CELLTRACKS AUTOPREP9541R9541R2016-09-22
10888385000665CELLTRACKS AUTOPREP954195412020-07-10
10888385000658CELLTRACKS ANALYZER II955595552020-07-10
10888385000016CellSearch790000179000012016-09-22
10888385000023CellSearch790000379000032016-09-22
10888385000047CellSave790000579000052016-09-22
10888385000054CELLTRACKS ANALYZER II955595552016-09-22
10888385000085CELLTRACKS ANALYZER II954295422016-09-22
10888385000627CELLTRACKS ANALYZER II9555R9555R2016-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08586015044823CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044830CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044847CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044854CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044861CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
08586015044878CHIRAVACCHIRANA T.Injecta, a. s.JKA2026-04-27
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10197344132928MEDLINEMEDLINE INDUSTRIES, INC.JKA2026-01-23
10850074089060SurgycoSurgyco LLCJKA2025-12-23
10850074089077SurgycoSurgyco LLCJKA2025-12-23
10850074089084SurgycoSurgyco LLCJKA2025-12-23
10850074089091SurgycoSurgyco LLCJKA2025-12-23
10850074089107SurgycoSurgyco LLCJKA2025-12-23
10850074089114SurgycoSurgyco LLCJKA2025-12-23
10612479275635McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
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10612479275840McKessonMCKESSON MEDICAL-SURGICAL INC.JKA2025-08-14
10193489189643MEDLINEMEDLINE INDUSTRIES, INC.JKA2025-07-10