Boekel Floor Standing Platelet Incubator Agitator FS100

GUDID 00863626000294

Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.

BOEKEL INDUSTRIES, INC.

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• Primary Device ID: 00863626000294
• NIH Device Record Key: 47656414-9e06-45b9-a315-e4c84e0ca46d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Boekel Floor Standing Platelet Incubator Agitator
• Version Model Number: FS100
• Catalog Number: FS100
• Company DUNS: 002288215
• Company Name: BOEKEL INDUSTRIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00863626000294 [Primary]

FDA Product Code

• KSH: Chamber, Environmental For The Storage Of Platelet Concentrate

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-06-16
• Device Publish Date: 2023-06-08

Devices Manufactured by BOEKEL INDUSTRIES, INC.

• 00863626000270 - Boekel Blood Collection Mixer: 2023-06-16 Device used for the collection of blood combined with a mixing motion.
• 00863626000294 - Boekel Floor Standing Platelet Incubator Agitator: 2023-06-16Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
• 00863626000294 - Boekel Floor Standing Platelet Incubator Agitator: 2023-06-16 Chamber that maintains 22 degrees C with constant agitation motion for the storage of Platelets.
• 00863626000218 - Boekel Small Platelet Agitator: 2019-05-24 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 Thawer: 2018-07-06
• 00863626000232 - Boekel Small Platelet Incubator: 2018-06-26
• 00863626000249 - Boekel Large Platelet Incubator: 2018-06-26
• 00863626000225 - Boekel Large Platelet Agitator: 2018-03-29 Large Platelet Agitator to continuously keep bags of Platelets moving. To be used alone or in conjunction with the Boekel Large