Duns Number:308667539
Device Description: D155 - REF 905-248 Disposable Waste Container for ABL5
Catalog Number
905-248
Brand Name
D155 - REF 905-248 Disposable Waste Container
Version/Model Number
905-248
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 15, 2020
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CHL
Product Code Name
Electrode measurement, blood-gases (pco2, po2) and blood ph
Public Device Record Key
8f5a80f8-d010-4d25-b598-9a5d2c9c8935
Public Version Date
August 19, 2022
Public Version Number
2
DI Record Publish Date
September 20, 2018
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 | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 66 |