AccessGUDID - DEVICE: Hematek® Stain Pak - Modified Wright's Stain (00630414473499)

GUDID

Device Identifier (DI) Information

Brand Name: Hematek® Stain Pak - Modified Wright's Stain
Version or Model: 10310965
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4481
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414473499
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064608573 *Terms of Use

Device Description: Hematek® Stain Pak Modified Wright's Stain

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?
43587	Biological stain IVD	A single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IAF	WRIGHT'S STAIN

FDA Premarket Submission

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

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
Special Storage Condition, Specify: Keep away from light and heat; protect from freezing; flammable; do not refrigerate; fragile
Handling Environment Temperature: between 15 and 25 Degrees Celsius
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cfb26ea5-f0b6-4af0-bf15-54a1fb57adde
Public Version Date: November 18, 2021
Public Version Number: 2
DI Record Publish Date: September 24, 2020