Duns Number:367919120
Device Description: Single Use Nasal Sampling Line, Large Adult Size, 2m/7ft
Catalog Number
878035
Brand Name
Vital Signs
Version/Model Number
878035
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
CCL
Product Code Name
ANALYZER, GAS, OXYGEN, GASEOUS-PHASE
Public Device Record Key
74dbfa38-626d-4598-9369-22c7b091cf6f
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
September 14, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 363 |