AccessGUDID - DEVICE: ExpoSure Biological Indicator (M985EXPO61)

GUDID

Device Identifier (DI) Information

Brand Name: ExpoSure Biological Indicator
Version or Model: 10e6
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EXPO/6
Company Name: MESA LABORATORIES, INC.

Primary DI Number: M985EXPO61
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 30
Labeler D-U-N-S® Number*: 102530326 *Terms of Use

Device Description: Self-contained biological indicator for use in a Sterrad hydrogen peroxide vessel

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 [?]
K140589	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: 0a79c74b-8c2d-4d93-bd0f-e9dcc15c65ad
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 26, 2016