FDA.reportPublic FDA data

Boekel Floor Standing Platelet Incubator Agitator

Primary DI
00863626000294
Brand
Boekel Floor Standing Platelet Incubator Agitator
Company
BOEKEL INDUSTRIES, INC.
Model
FS100
Catalog number
FS100
Device description
Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KSHChamber, Environmental For The Storage Of Platelet Concentrate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KSHChamber, Environmental For The Storage Of Platelet ConcentrateHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00863626000294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863626000294008636260002948636260002940863626000294

GMDN Terms#

Term, Definition table
TermDefinition
Platelet incubatorAn electrically-powered device intended to be used to store and/or transport platelet concentrates while keeping them warm (typically from 20° to 24° Celsius). It is a cabinet-like chamber with shelves, and typically includes built-in temperature displays and an alarm triggered by out-of-range temperature variations; some types may in addition have built-in platelet agitators.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002288215
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00863626000270Boekel Blood Collection Mixer3020003020002023-06-08
00863626000201Boekel Plasma Thawer3010002016-09-01
00863626000218Boekel Small Platelet Agitator3012003012002019-05-16
00863626000232Boekel Small Platelet Incubator3015502016-09-01
00863626000249Boekel Large Platelet Incubator3016502016-09-01
00863626000225Boekel Large Platelet Agitator3013002017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816394021664HelmerHELMER, INC.KSH2022-12-30
00816394021671HelmerHELMER, INC.KSH2022-12-01
00816394021688HelmerHELMER, INC.KSH2022-12-01
00816394020940HelmerHELMER, INC.KSH2019-02-08
00816394020957HelmerHELMER, INC.KSH2019-02-08
00816394020964HelmerHELMER, INC.KSH2019-02-08
00863626000232Boekel Small Platelet IncubatorBOEKEL INDUSTRIES, INC.KSH2016-09-01
00863626000249Boekel Large Platelet IncubatorBOEKEL INDUSTRIES, INC.KSH2016-09-01
00816394020674Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020681Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020698Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020704Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020711Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020728Horizon Series™ HELMER, INC.KSH2016-07-01
00816394020735i.Series® HELMER, INC.KSH2016-07-01
00816394020742i.Series® HELMER, INC.KSH2016-07-01
00816394020759i.Series® HELMER, INC.KSH2016-07-01
00816394020766i.Series® HELMER, INC.KSH2016-07-01
00816394020773i.Series® HELMER, INC.KSH2016-07-01
00816394020780i.Series® HELMER, INC.KSH2016-07-01