AccessGUDID - DEVICE: ChemSTAT Hematocrit Evaluator 2 (08426951293834)

GUDID

Device Identifier (DI) Information

Brand Name: ChemSTAT Hematocrit Evaluator 2
Version or Model: 00044000105
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00044000105
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426951293834
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: ChemSTAT Hematocrit Evaluator 2, 10 ampoules x 1.8 mL

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):	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?
52868	Multiple electrolyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple electrolytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GLK	Control, Hematocrit

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 25 Degrees Celsius
Special Storage Condition, Specify: Unopened ampuoles are stable until the expiration date shown on the label when stored at room temperature (15- 25°C). DO NOT FREEZE.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86565820-38a1-4ad4-8b43-eafb32f0818f
Public Version Date: July 13, 2021
Public Version Number: 3
DI Record Publish Date: June 26, 2019