FDA.reportPublic FDA data

HemoFlow

Primary DI
00850047037084
Brand
HemoFlow
Company
Applied Science, Inc.
Model
9-0500-0001
Device description
HemoFlow 500 Basic/Blood Donation Rocker
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
00850047037084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047037084008500470370848500470370840850047037084

GMDN Terms#

Term, Definition table
TermDefinition
Blood donation rockerA mains electricity (AC-powered), electromechanical device intended to maintain blood homogeneity through a continuous rocking motion. It is mostly used in a blood donor unit, department, or mobile unit, where the blood is kept in motion as it is drawn from the blood donor and runs into a blood donor bag or a set of collection tubes which lie in a cradle-like holder attached to this device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
5332738299angela_redfield@applied-science.com

Regulatory Flags#

DUNS number
068878946
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047037077HemoFlow9-0500-00022024-03-11
00850047037053HemoFlow9-0000-05042023-09-08
00850047037022HemoFlow9-0000-00042023-03-14
00850047037039HemoFlow9-0000-01062023-03-03
00850047037046HemoFlow9-0000-01072023-03-03
00850047037008HemoFlow9-4000-03002023-02-21
00850047037015HemoFlow9-4001-03002023-02-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00866305000288Genesis Tube StripperGENESIS BPS LLCKSQ2025-01-31
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
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
10810020440345Fresenius 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