AccessGUDID - DEVICE: Cal-Chex A Plus (40844509000318)

GUDID

Device Identifier (DI) Information

Brand Name: Cal-Chex A Plus
Version or Model: 221108
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 221108
Company Name: STRECK, INC.

Primary DI Number: 40844509000318
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 072915986 *Terms of Use

Device Description: A hematology calibrator assayed for the Abbott CELL-DYN® 3200, 3500, 3700 and Ruby® analyzers. Contains 2 vials.

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:	Yes
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?
55865	Full blood count IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of one or multiple whole blood cell parameters in a clinical specimen [also known as complete blood count (CBC)]. Test components may include white cell count and differential, red cell count and calculation of red cell parameters and/or platelet count.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KRX	Calibrator For Cell Indices
KSA	Calibrator For Red-Cell And White-Cell Counting
KRY	Calibrator For Platelet Counting
KRZ	Calibrator For Hemoglobin And Hematocrit Measurement

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K020469	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
Storage Environment Temperature: between 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 3.0 Milliliter

Device Record Status

Public Device Record Key: 58d81e35-55f3-433f-bb15-234a692ed177
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 16, 2016