AccessGUDID - DEVICE: Boekel Large Platelet Incubator (00863626000249)

GUDID

Device Identifier (DI) Information

Brand Name: Boekel Large Platelet Incubator
Version or Model: 301650
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BOEKEL INDUSTRIES, INC.

Primary DI Number: 00863626000249
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002288215 *Terms of Use

Device Description: No description.

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?
62158	Platelet incubator	An electrically-powered device intended to be used to store and/or transport platelet concentrates while keeping them warm (typically from 20° to 24° Celsius). It is a cabinet-like chamber with shelves, and typically includes built-in temperature displays and an alarm triggered by out-of-range temperature variations; some types may in addition have built-in platelet agitators.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KSH	Chamber, Environmental For The Storage Of Platelet Concentrate

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: 3de467a7-a182-42a5-891f-0b9335e2f1c0
Public Version Date: June 26, 2018
Public Version Number: 3
DI Record Publish Date: September 01, 2016