AccessGUDID - DEVICE: Boekel Large Platelet Agitator (00863626000225)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 00863626000225
Issuing Agency: GS1
Device Count: 1

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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
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.

FDA Product Code

[?]

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

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: January 31, 2017
Commercial Distribution End Date:

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES

DEVICE: Boekel Large Platelet Agitator (00863626000225)