AccessGUDID - DEVICE: Tyson Bio HT100 Control Solution Level 3 (04719869701954)

GUDID

Device Identifier (DI) Information

Brand Name: Tyson Bio HT100 Control Solution Level 3
Version or Model: HT100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TYSON BIORESEARCH INC.

Primary DI Number: 04719869701954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 658026104 *Terms of Use

Device Description: No description.

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):	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?
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
NBW	System, Test, Blood Glucose, Over The Counter

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K170079	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35b64a51-b00d-4f5d-9ef4-e63a52b15384
Public Version Date: February 20, 2023
Public Version Number: 3
DI Record Publish Date: July 17, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status
14719869701951	50	04719869701954	In Commercial Distribution
24719869701958	1000	04719869701954	In Commercial Distribution
34719869701955	20	04719869701954	In Commercial Distribution