AccessGUDID - DEVICE: Easy Talk (04719871820209)

GUDID

Device Identifier (DI) Information

Brand Name: Easy Talk
Version or Model: GOD11(BZL002HA)
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOTEST MEDICAL CORPORATION

Primary DI Number: 04719871820209
Issuing Agency: GS1
Commercial Distribution End Date: May 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 658447255 *Terms of Use

Device Description: Easy Talk Control Solution-Low(Box)

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):	Yes
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?
41819	Glucose IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of glucose in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGA	Glucose Oxidase, Glucose
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)
NBW	System, Test, Blood Glucose, Over The Counter

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 55378853-abd2-4e11-9bff-c57c253d0050
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: May 02, 2016