AccessGUDID - DEVICE: Saliva-Check (D6589002001)

GUDID

Device Identifier (DI) Information

Brand Name: Saliva-Check
Version or Model: 900200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900200
Company Name: Gc America Inc.

Primary DI Number: D6589002001
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 20
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: Saliva-Check Buffer Kit Contains: 20-in vitro pH test strips pH 5.0-8.0, saliva collection cups, wax for saliva stimulation, saliva dispensing pipettes, buffer test strips

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):	Yes
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?
61719	Saliva pH IVD, kit, rapid colorimetric, clinical	A collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of salivary pH within a short period, relative to standard laboratory testing procedures, using a rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. Saliva pH is an indicator of oral health and a prolonged acidic environment is associated with erosion of tooth enamel, dental caries, or eventually periodontal disease. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGD	WAX, DENTAL, INTRAORAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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 15 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7af05b8-d855-49f6-ab77-e6a8dde89251
Public Version Date: January 21, 2026
Public Version Number: 6
DI Record Publish Date: February 10, 2017