Duns Number:022721133
Device Description: Gas Sampling Line .047" ID x 96" length P/PV with Male/Female Luer Lock Connectors, 5.0um Gas Sampling Line .047" ID x 96" length P/PV with Male/Female Luer Lock Connectors, 5.0um Hydrophobic Filter, PTFE, 25 mmObsoleted 12-15-2019, marketing sku reduction project.
Catalog Number
ZML-9441-1
Brand Name
N/A
Version/Model Number
ZML-9441-1
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 15, 2019
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"
Yes
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
K930957,K930957
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
5614c96d-4533-4408-b902-2b794f03648c
Public Version Date
March 22, 2022
Public Version Number
5
DI Record Publish Date
May 12, 2017
Package DI Number
10607411940610
Quantity per Package
50
Contains DI Package
00690741194061
Package Discontinue Date
December 15, 2019
Package Status
Not in Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 865 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1134 |