AccessGUDID - DEVICE: Rapid Response (00722066001936)

GUDID

Device Identifier (DI) Information

Brand Name: Rapid Response
Version or Model: U120
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BTNX Inc

Primary DI Number: 00722066001936
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 251005005 *Terms of Use

Device Description: Urine Analyzer 120

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:	No
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?
57861	Urine analyser IVD, point-of-care	A mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LJX	Test, Urine Leukocyte
JRE	Refractometer For Clinical Use
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)
JIR	Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
JIO	Blood, Occult, Colorimetric, In Urine
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)
JIL	Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
CEN	Dye-Indicator, Ph (Urinary, Non-Quantitative)
CDM	Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
KQO	Automated Urinalysis System

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K070929	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: 77c92f02-79ba-4133-a507-fca511a6cb3d
Public Version Date: April 20, 2023
Public Version Number: 2
DI Record Publish Date: October 16, 2019

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: Yes
DM DI Number: 00722066005064
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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