AccessGUDID - DEVICE: BIOlogical10 (10850065007837)

GUDID

Device Identifier (DI) Information

Brand Name: BIOlogical10
Version or Model: 3703
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3703
Company Name: HF ACQUISITION CO. LLC

Primary DI Number: 10850065007837
Issuing Agency: GS1
Commercial Distribution End Date: January 16, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 045657305 *Terms of Use

Device Description: Biological In Office Monitoring - 10 Hour

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?
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 [?]
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
Special Storage Condition, Specify: Do not store indicators near sterilants or other chemicals.
Special Storage Condition, Specify: Store BIOlogical10 indicators at room temperature.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83e6a9cc-31f0-48ba-a5f1-12dd6b148488
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: December 11, 2016