AccessGUDID - DEVICE: Smart-Read EZTest Biological Test Pack (M985SRSP250)

GUDID

Device Identifier (DI) Information

Brand Name: Smart-Read EZTest Biological Test Pack
Version or Model: 10e5/25 controls
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SRSP/25
Company Name: MESA LABORATORIES, INC.

Primary DI Number: M985SRSP250
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102530326 *Terms of Use

Device Description: Mesa Labs Smart Read EZTest Biological Test Pack with Instant Readout Integrator

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?
13732	Biological sterilization indicator	A sterilization indicator consisting of a standardized, viable population of microorganisms (e.g., bacterial spores known to be resistant to the mode of sterilization being monitored) that will display a change when exposed to an effective sterilization outcome indicating that sterilization parameters have been met. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRC	Indicator, Biological Sterilization Process

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K103000	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: b1a4af66-ed48-444a-9c67-1eb8c8de8acf
Public Version Date: December 07, 2018
Public Version Number: 3
DI Record Publish Date: August 30, 2016