AccessGUDID - DEVICE: Rapid Response (00722066005231)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: U2.2-1S100
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTNX Inc

Primary DI Number: 00722066005231
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 100
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: Rapid Response 2 Parameter Urinalysis Reagent Strips (pH/S.g.) - 100 tests/ kit are for the qualitative or semi-quantitative detection of pH and specific gravity in urine.

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:	Yes
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?
54522	Urine 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 urine to determine 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. It is not intended to be used for self-testing.	Active	false
54524	Urine specific gravity 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 urine to determine specific gravity 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. It is not intended to be used for self-testing.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K061559	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b910334f-ff9c-40ae-8dc3-a857059b3833
Public Version Date: April 20, 2023
Public Version Number: 3
DI Record Publish Date: December 14, 2020