Duns Number:600111512
Device Description: OMNISTREAM OMNILINE ADULT ORAL-NASAL SAMPLING LINE O2 2M 25
Catalog Number
010177COV-05
Brand Name
Omnistream
Version/Model Number
010177COV-05
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K013845,K013845
Product Code
CCK
Product Code Name
ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
Public Device Record Key
6eae04bf-054f-4751-b0e9-ec56e3d553a5
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
November 21, 2017
Package DI Number
10884521531598
Quantity per Package
25
Contains DI Package
20884521531595
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 154 |