Boekel Large Platelet Agitator

GUDID 00863626000225

Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550

BOEKEL INDUSTRIES, INC.

Platelet agitator
Primary Device ID00863626000225
NIH Device Record Key4dce0be2-4f99-4cd2-9e20-f6d85e12ce0e
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoekel Large Platelet Agitator
Version Model Number301300
Company DUNS002288215
Company NameBOEKEL INDUSTRIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone216-989-1143
Emailrrink@boekelsci.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100863626000225 [Primary]

FDA Product Code

KSQDevice, Blood Mixing And Blood Weighing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-01-31

Devices Manufactured by BOEKEL INDUSTRIES, INC.

00863626000270 - Boekel Blood Collection Mixer2023-06-16 Device used for the collection of blood combined with a mixing motion.
00863626000294 - Boekel Floor Standing Platelet Incubator Agitator2023-06-16 Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
00863626000218 - Boekel Small Platelet Agitator2019-05-24 Device used to agitate platelets. May be used alone if temperature can be maintained to 22 degrees C +/- 2 degrees. may be use
00863626000201 - Boekel Plasma Thawer2018-07-06
00863626000232 - Boekel Small Platelet Incubator2018-06-26
00863626000249 - Boekel Large Platelet Incubator2018-06-26
00863626000225 - Boekel Large Platelet Agitator2018-03-29Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large Platelet Incubator 301550
00863626000225 - Boekel Large Platelet Agitator2018-03-29 Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.