Duns Number:007941230
Device Description: Cannula Carbon Dioxide Oxygen Sampling Comfort Soft Plus 7 Foot Tubing With Female Luer 2 Cannula Carbon Dioxide Oxygen Sampling Comfort Soft Plus 7 Foot Tubing With Female Luer 2 Inch Pigtail Connector Adult Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
RSP6121A
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"
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
-
Product Code
CAT
Product Code Name
CANNULA, NASAL, OXYGEN
Public Device Record Key
0bd4599e-2a81-4619-9b64-b0341d4fcc95
Public Version Date
March 22, 2022
Public Version Number
2
DI Record Publish Date
October 05, 2020
Package DI Number
50885632130326
Quantity per Package
25
Contains DI Package
10885632130328
Package Discontinue Date
-
Package Status
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 | 428 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8754 |
| U | Unclassified | 1 |