AccessGUDID - DEVICE: DxH (15099590209636)

GUDID

Device Identifier (DI) Information

Brand Name: DxH
Version or Model: B01276
Commercial Distribution Status: In Commercial Distribution
Catalog Number: B01276
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590209636
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: Beckman Coulter DxH Slides are microscopic slides intended to be used to prepare whole blood samples for histological stains and preservation of blood for microscopic evaluation. Beckman Coulter DxH Slides are 25 x 75 x 1 mm glass microscope slides with white or painted frosted ends. Beckman Coulter DxH Slides are used with the DxH Slidemaker Stainers, fully automated slide preparation and staining devices that smear a blood film on a clean microscope slide, and deliver a variety of fixatives, stains, buffers, and rinse solutions to the blood smear on the slide.

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):	Yes
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?
57925	General specimen microscopy slide IVD, single-use	A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use

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
Storage Environment Temperature: between 15 and 30 Degrees Celsius
Special Storage Condition, Specify: Keep Dry

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e528114f-02fd-4385-983f-978e1ed77669
Public Version Date: November 19, 2024
Public Version Number: 1
DI Record Publish Date: November 11, 2024