AccessGUDID - DEVICE: Getinge Assured Self-Contained Biological Indicator EO (00814434020790)

GUDID

Device Identifier (DI) Information

Brand Name: Getinge Assured Self-Contained Biological Indicator EO
Version or Model: 504054000, 6130160671
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 504054000, 6130160671
Company Name: STERITEC PRODUCT MFG. CO., INC.

Primary DI Number: 00814434020790
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622223196 *Terms of Use

Device Description: 504054000 - Case of 4 boxes of 100 6130160671 - Box of 50

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 [?]
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: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: decffe2a-f990-4275-b6a3-61b288c33d78
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
20814434020794	4	10814434020797	In Commercial Distribution	Case
10814434020797	100	00814434020790	In Commercial Distribution	Box
30814434020791	50	00814434020790	In Commercial Distribution	Box