FDA.reportPublic FDA data

Adaptive Nomogram Transfer Pack

Primary DI
00810020440515
Brand
Adaptive Nomogram Transfer Pack
Company
Fresenius Kabi AG
Model
7R2090
Catalog number
7R2090
Device description
For processing and/or storage of blood and blood components. Sterile Fluid Path
Published
2024-12-12
Public version status
New
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
KSRContainer, Empty, For Collection & Processing Of Blood & Blood Components

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSRContainer, Empty, For Collection & Processing Of Blood & Blood ComponentsHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020440512PackageGS150In Commercial Distribution
00810020440515PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002044051210810020440512
00810020440515008100204405158100204405150810020440515

GMDN Terms#

Term, Definition table
TermDefinition
Blood/tissue storage/culture containerA receptacle intended for the storage and/or culture of tissue, cells, blood or blood components (e.g., peripheral blood stem cells) typically for subsequent therapeutic applications. It has a variety of shapes and sizes, may reduce the risk of contamination, may be used during freezing, and may be gas permeable. 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
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30812747019815Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
00812747019814Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONKSR2025-07-16
10816203023909CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024050CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024067CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024203CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024210CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024227CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024234CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024241CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024258CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024289CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024302CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
10816203024319CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203023906CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024057CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024064CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024200CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024217CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024224CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024231CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024248CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024255CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024286CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024309CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
20816203024316CryoStore Freezing BagORIGEN BIOMEDICAL, INC.KSR2025-06-18
00810020441741Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
10810020441748Adaptive Nomogram BottleFresenius Kabi AGKSR2025-03-14
00810020441383Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15
10810020441380Plasmalink Bottle 1000 mL with locking luer adapterFresenius Kabi AGKSR2025-01-15