AccessGUDID - DEVICE: ADVIA Autoslide® Slide Maker Stainer (00630414560595)

GUDID

Device Identifier (DI) Information

Brand Name: ADVIA Autoslide® Slide Maker Stainer
Version or Model: 10282177
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 085-A001-02
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414560595
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: ADVIA® Autoslide Slide Maker Stainer

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:	Yes
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?
37974	Microscope slide maker/stainer IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KPA	SLIDE STAINER, AUTOMATED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051693	000

Device Exempt from Premarket Submission: No 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: 1d180a81-c7da-485f-b732-c8c06c018742
Public Version Date: September 16, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020