FDA.reportPublic FDA data

Hematype Segment Device

Primary DI
10810020440536
Brand
Hematype Segment Device
Company
Fresenius Kabi AG
Model
4R5128
Catalog number
4R5128
Device description
Hematype Segment Device
Published
2022-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KSSSupplies, Blood-Bank

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSSSupplies, Blood-BankHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK9600830

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK9600830

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810020440533PackageGS12In Commercial Distribution
10810020440536PrimaryGS10
00810020440539Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081002044053320810020440533
1081002044053610810020440536
00810020440539008100204405398100204405390810020440539

GMDN Terms#

Term, Definition table
TermDefinition
Blood collection tube holder, single-useA hand-held cylindrical device designed to be used together with an evacuated blood collection tube to draw blood samples from a patient. It is typically a hollow plastic adaptor into which the blood collection tube is inserted and to which the user attaches a hypodermic blood collection needle (not included); it may include an integrated blood collection tube spike. This device also facilitates a multiple-tube blood collection via one venipuncture. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Regulatory Flags#

DUNS number
315654579
Device count
500
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03
00810020441062Fenwal Hand Sealer4R4454W4R4454W2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540151300121RadTagRadtag Technologies IncKSS2025-12-30
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07540151300145RadTagRadtag Technologies IncKSS2025-12-30
07540151300152RadTagRadtag Technologies IncKSS2025-12-30
05060242472596ORTHO® Elution KitALBA BIOSCIENCE LIMITEDKSS2025-12-04
09555240405616SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
19555240405613SampLok® Sampling Kit 16mLITL ASIA PACIFIC SDN. BHD.KSS2025-06-04
07540151300107AccuTagRadtag Technologies IncKSS2023-11-02
05060242477959ALBA Elution KitALBA BIOSCIENCE LIMITEDKSS2023-10-13
00810106410333Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410340Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-05-10
00810106410326Rad-Sure™ASHLAND SPECIALTY INGREDIENTS G.P.KSS2023-04-24
07540151300046RadTagRadtag Technologies IncKSS2022-12-02
07540151300053RadTagRadtag Technologies IncKSS2022-12-02
07540151300060RadTagRadtag Technologies IncKSS2022-12-02
07540151300077RadTagRadtag Technologies IncKSS2022-12-02
07540151300008RadTagRadtag Technologies IncKSS2022-12-01
07540151300015RadTagRadtag Technologies IncKSS2022-12-01
07540151300022RadTagRadtag Technologies IncKSS2022-12-01
07540151300039RadTagRadtag Technologies IncKSS2022-12-01
10812269031230Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031254Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
10812269031278TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
10812269031285TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031240Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
00812269031264Typesafe 2.0TYPENEX MEDICAL LLCKSS2022-11-21
20812269031275TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
00812269031295TypesafeTYPENEX MEDICAL LLCKSS2022-11-21
20810020440533Hematype Segment DeviceFresenius Kabi AGKSS2022-11-08
04086000860161CompoMat G5 PlusFresenius Kabi AGKSS2022-11-07