AccessGUDID - DEVICE: CAL B (05055273205954)

GUDID

Device Identifier (DI) Information

Brand Name: CAL B
Version or Model: RX3949
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RX3949
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273205954
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The product is intended to be used as a second Calibrator in a two-point calibration. Calibrator B is aspirated from a sample cup at position 18 on the analyser ASP tray at least once every 8 hours depending on the laboratories schedule.

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?
47868	Multiple-type clinical chemistry analyte profile IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of multiple types of clinical chemistry analytes (e.g., combination of electrolytes, hormones, and proteins) in a clinical specimen, which contribute to or create a full general biochemistry profile.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JIX	Calibrator, Multi-Analyte Mixture

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024014	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
Special Storage Condition, Specify: Once opened, Calibrator B is stable for 1 month at + 15 to + 25°C. Close tightly between each use.
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 33c17e29-13ac-45f8-a101-63947f483a48
Public Version Date: December 21, 2020
Public Version Number: 4
DI Record Publish Date: September 26, 2016