FDA.reportPublic FDA data

Fresenius Kabi Adjustable Automatic Donor Scale Support Stand

Primary DI
10810020440345
Brand
Fresenius Kabi Adjustable Automatic Donor Scale Support Stand
Company
Fresenius Kabi AG
Model
Version A
Catalog number
4R4408
Device description
Adjustable Automatic Donor Scale Support Stand
Published
2021-08-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KSQDevice, Blood Mixing And Blood Weighing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSQDevice, Blood Mixing And Blood WeighingHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810020440345PackageGS11In Commercial Distribution
00810020440348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081002044034510810020440345
00810020440348008100204403488100204403480810020440348

GMDN Terms#

Term, Definition table
TermDefinition
Mechanical analytical balanceA mechanical laboratory instrument designed for weighing with a high degree of accuracy and precision. It will typically have a weighing range of up to 200 grams with a readability from 0.01 to 0.1 mg. The device will usually include an integrated weighing chamber.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00For mobile operations, remove weight before transporting stand.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315654579
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

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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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04086000860888COMPOGUARD Advance BasicFresenius Kabi AGKSQ2024-10-30
04086000860895COMPOGUARD Advance DataFresenius Kabi AGKSQ2024-10-29
04086000860901COMPOGUARD Advance COMPLETEFresenius Kabi AGKSQ2024-10-29
00850047037077HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037084HemoFlowApplied Science, Inc.KSQ2024-03-11
00850047037053HemoFlowApplied Science, Inc.KSQ2023-09-08
00863626000270Boekel Blood Collection MixerBOEKEL INDUSTRIES, INC.KSQ2023-06-08
00850047037022HemoFlowApplied Science, Inc.KSQ2023-03-14
00850047037039HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037046HemoFlowApplied Science, Inc.KSQ2023-03-03
00850047037008HemoFlowApplied Science, Inc.KSQ2023-02-21
00850047037015HemoFlowApplied Science, Inc.KSQ2023-02-21
04038917141154Tube- Stripper AST-2Sarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04038917258869Tube-Stripper AST-2SSarstedt Aktiengesellschaft & Co.KGKSQ2022-11-30
04086000860741CompoGuard Basic (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860758CompoGuard Data (NA)Fresenius Kabi AGKSQ2022-11-10
04086000860765CompoGuard Complete (NA)Fresenius Kabi AGKSQ2022-11-10
00810020440065Donor Tube StripperFresenius Kabi AGKSQ2022-11-04
00810020440348Fresenius Kabi Adjustable Automatic Donor Scale Support StandFresenius Kabi AGKSQ2021-08-18
04028339620139TRANSWAAGTransmed Medizintechnik GmbH & Co. KGKSQ2020-09-01
08809241446224Blood Collection Monitor CM350CENTRON CORPORATIONKSQ2020-04-17
08809241446132Blood Collection Mixer CM735ACENTRON CORPORATIONKSQ2020-04-03
08809241446446Data Collection Mixer DCM3000 (BASIC)CENTRON CORPORATIONKSQ2020-04-03
00863626000218Boekel Small Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2019-05-16
00816394020971HelmerHELMER, INC.KSQ2019-02-08
00816394020988HelmerHELMER, INC.KSQ2019-02-08
00816394020995HelmerHELMER, INC.KSQ2019-02-08
00863626000225Boekel Large Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2017-01-31
00816394020797i.Series® HELMER, INC.KSQ2016-07-01