AccessGUDID - DEVICE: BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2) (05055273227116)

GUDID

Device Identifier (DI) Information

Brand Name: BLOOD GAS CONTROL - LEVEL 2 (BG CONTROL 2)
Version or Model: BG5002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: BG5002
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273227116
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: No description.

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?
30218	Multiple blood gas analyte IVD, control	A material which is used to verify the performance of a number of assays intended to be used for the quantitative measurement of one or multiple blood gas analytes in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJY	Multi-Analyte Controls, All Kinds (Assayed)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K093384	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: 75c9b98a-ab5c-47d9-aaab-406b63c0c586
Public Version Date: June 12, 2019
Public Version Number: 1
DI Record Publish Date: June 04, 2019