FDA.report

HemoFlow

Primary DI
00850047037008
Brand
HemoFlow
Company
Applied Science, Inc.
Model
9-4000-0300
Device description
HemoFlow 400 Basic/Blood Donation Rocker
Published
2023-02-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
KSQDevice, Blood Mixing And Blood Weighing

Product Code Classifications

CodeDeviceSpecialtyClass
KSQDevice, Blood Mixing And Blood WeighingHematology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850047037008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047037008008500470370088500470370080850047037008

GMDN Terms

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

Contacts

PhoneEmail
5332738299brenda_arnold@applied-science.com

Regulatory Flags

DUNS number
068878946
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

Primary DIBrandModelCatalogPublished
00850047037077HemoFlow9-0500-00022024-03-11
00850047037084HemoFlow9-0500-00012024-03-11
00850047037053HemoFlow9-0000-05042023-09-08
00850047037022HemoFlow9-0000-00042023-03-14
00850047037039HemoFlow9-0000-01062023-03-03
00850047037046HemoFlow9-0000-01072023-03-03
00850047037015HemoFlow9-4001-03002023-02-21

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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
00850047037015HemoFlowApplied Science, Inc.KSQ2023-02-21
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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
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
00816394020971i.Series®HELMER, INC.KSQ2019-02-08
00816394020988i.Series®HELMER, INC.KSQ2019-02-08
00816394020995i.Series®HELMER, INC.KSQ2019-02-08
00863626000225Boekel Large Platelet AgitatorBOEKEL INDUSTRIES, INC.KSQ2017-01-31
00816394020797i.Series® HELMER, INC.KSQ2016-07-01
00816394020803i.Series® HELMER, INC.KSQ2016-07-01