AccessGUDID - DEVICE: ContrIL 7 Level 1 (08426950087847)

GUDID

Device Identifier (DI) Information

Brand Name: ContrIL 7 Level 1
Version or Model: 00024001381
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00024001381
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950087847
Issuing Agency: GS1
Commercial Distribution End Date: December 29, 2023
Device Count: 30
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: ContrIL 7 Level 1

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):	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?
52860	Multiple blood gas/haemoximetry/electrolyte analyte IVD, control	A material which is used to verify the performance of an assay intended to be used for the quantitative measurement of multiple blood gas, haemoximetry and/or electrolyte analytes in a clinical sample. Analytes detected may include partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, sodium, potassium, ionized calcium, chloride, glucose, lactate, total haemoglobin (totHb), haematocrit, and haemoglobin derivatives such as reduced haemoglobin (RHb), methaemoglobin (MetHb), sulfhaemoglobin (SHb).	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 [?]
Premarket Submission Number Not Available/Not Released

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: Store ContrIL 7 at 15-25 °C. Do not refrigerate. Protect from direct sunlight. For optimum results store ContrIL 7 for at least 8 hours prior to use at 25 °C.
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: 8b5aa9a2-c020-49a8-8f33-960fac1a7802
Public Version Date: January 01, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016