AccessGUDID - DEVICE: SteriTec Green Card Bowie-Dick Test (00814434020028)

GUDID

Device Identifier (DI) Information

Brand Name: SteriTec Green Card Bowie-Dick Test
Version or Model: BD 115
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BD 115, BD 115/120
Company Name: STERITEC PRODUCT MFG. CO., INC.

Primary DI Number: 00814434020028
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 622223196 *Terms of Use

Device Description: BD 115 = 960 Tests BD 115/120 = 120 Tests

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?
35362	Chemical/physical sterilization process indicator	A sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). 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: 678658f9-71c9-4298-b1b8-7303caa79b64
Public Version Date: February 21, 2025
Public Version Number: 4
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
30814434020029	8	20814434020022	In Commercial Distribution	Carton
20814434020022	4	10814434020025	In Commercial Distribution	Case
10814434020025	30	00814434020028	In Commercial Distribution	Bag
70814434020027	30	00814434020028	In Commercial Distribution	Bag
80814434020024	4	70814434020027	In Commercial Distribution	Case