AccessGUDID - DEVICE: Boekel Large Platelet Agitator (00863626000225)

GUDID

Device Identifier (DI) Information

Brand Name: Boekel Large Platelet Agitator
Version or Model: 301300
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOEKEL INDUSTRIES, INC.

Primary DI Number: 00863626000225
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002288215 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
45226	Platelet agitator	A mains electricity (AC-powered), electromechanical device typically used by blood bank and transfusion services to provide gentle agitation (e.g., side-to-side motion) required for platelet storage. The device will typically provide several drawers on which to place containers of platelets. It may include an audible alarm that sounds if agitation does not occur during use.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSQ	Device, Blood Mixing And Blood Weighing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 4dce0be2-4f99-4cd2-9e20-f6d85e12ce0e
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: January 31, 2017