Boekel Plasma Thawer

GUDID 00863626000201

BOEKEL INDUSTRIES, INC.

Plasma thawing unit
Primary Device ID00863626000201
NIH Device Record Key50bee903-a03b-4ef9-b5b8-1c63d2ee114a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBoekel Plasma Thawer
Version Model Number301000
Company DUNS002288215
Company NameBOEKEL INDUSTRIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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

Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com
Phone267-989-1143
Emailrrink@boekelsci.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100863626000201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KZLDevice, Warming. Blood And Plasma

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-01

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
00863626000201 - Boekel Plasma Thawer2018-07-06
00863626000232 - Boekel Small Platelet Incubator2018-06-26
00863626000249 - Boekel Large Platelet Incubator2018-06-26
00863626000225 - Boekel Large Platelet Agitator2018-03-29 Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large

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