FDA.reportPublic FDA data

Boekel Large Platelet Incubator

Primary DI
00863626000249
Brand
Boekel Large Platelet Incubator
Company
BOEKEL INDUSTRIES, INC.
Model
301650
Published
2016-09-01
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
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
00863626000249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00863626000249008636260002498636260002490863626000249

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

Contacts#

Phone, Email table
PhoneEmail
267-989-1143rrink@boekelsci.com

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
00863626000294Boekel Floor Standing Platelet Incubator AgitatorFS100FS1002023-06-08
00863626000201Boekel Plasma Thawer3010002016-09-01
00863626000218Boekel Small Platelet Agitator3012003012002019-05-16
00863626000232Boekel Small Platelet Incubator3015502016-09-01
00863626000225Boekel Large Platelet Agitator3013002017-01-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00863626000294Boekel Floor Standing Platelet Incubator AgitatorBOEKEL INDUSTRIES, INC.KSH2023-06-08
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
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