AccessGUDID - DEVICE: ContrIL Spectrum Control, Level 1 (08426950029168)

GUDID

Device Identifier (DI) Information

Brand Name: ContrIL Spectrum Control, Level 1
Version or Model: 00009833750
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 00009833750
Company Name: INSTRUMENTATION LABORATORY COMPANY

Primary DI Number: 08426950029168
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2018
Device Count: 50
Labeler D-U-N-S® Number*: 557223252 *Terms of Use

Device Description: ContrIL Spectrum Control, 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):	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?
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
JJS	CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store ContrIL Spectrum at 2-8°C (the product is stable for only 120 days if stored at 15- 25°C). Protect from direct sunlight.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5d3728a2-4f59-432c-8c04-db5aad2ce85a
Public Version Date: July 13, 2021
Public Version Number: 5
DI Record Publish Date: September 23, 2016