AccessGUDID - DEVICE: SteriTec Biological Test Pack with Instant Readout Integrator (00814434020042)

GUDID

Device Identifier (DI) Information

Brand Name: SteriTec Biological Test Pack with Instant Readout Integrator
Version or Model: BI 103
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BI 103
Company Name: STERITEC PRODUCT MFG. CO., INC.

Primary DI Number: 00814434020042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622223196 *Terms of Use

Device Description: Biological Test Pack with Instant Readout Integrator with 5 controls

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
JOJ	Indicator, Physical/Chemical 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
Storage Environment Temperature: between 10 and 38 Degrees Celsius
Storage Environment Humidity: between 10 and 70 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e993c532-108e-4c5f-9718-7983be5b29cf
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016