AccessGUDID - DEVICE: Hematek® Stain Pak - Wright-Giemsa Stain (00630414473482)

GUDID

Device Identifier (DI) Information

Brand Name: Hematek® Stain Pak - Wright-Giemsa Stain
Version or Model: 10314755
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4405
Company Name: Siemens Healthcare Diagnostics Inc.

Primary DI Number: 00630414473482
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 Wright-Giemsa 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
HYF	GIEMSA 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: Protect from freezing; Fragile; Protect from light & heat; Flammable
Storage Environment Temperature: between 15 and 25 Degrees Celsius
Handling Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 527d00f8-2f03-4194-b45f-61794f3b8604
Public Version Date: April 29, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2020