Duns Number:051624070
Device Description: Liquichek Blood Gas Plus CO-Oximeter Control Level 2 (An aqueous assayed blood gas, electr Liquichek Blood Gas Plus CO-Oximeter Control Level 2 (An aqueous assayed blood gas, electrolyte, metabolite and CO-Oximeter control.)
Catalog Number
505
Brand Name
Liquichek
Version/Model Number
505
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2018
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K003239
Product Code
JJS
Product Code Name
CONTROLS FOR BLOOD-GASES, (ASSAYED AND UNASSAYED)
Public Device Record Key
079a8d26-f17d-4306-97db-96969d08b031
Public Version Date
July 16, 2018
Public Version Number
4
DI Record Publish Date
December 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 511 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 428 |
| U | Unclassified | 1 |