Duns Number:092673953
Device Description: Composite Respiratory Kit: Nationwide Medical6-0556B, 1-0021B, 1-0014B, 1-0027B, 1-No Smok Composite Respiratory Kit: Nationwide Medical6-0556B, 1-0021B, 1-0014B, 1-0027B, 1-No Smoking Sign, 1-0590B, 1-Cylinder Wrench
Catalog Number
-
Brand Name
Composite Respiratory Kit: Nationwide Medical
Version/Model Number
0837
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
33e01839-e3e3-4b61-9808-8680bd02b3d8
Public Version Date
August 05, 2022
Public Version Number
4
DI Record Publish Date
April 19, 2017
Package DI Number
10709078002592
Quantity per Package
10
Contains DI Package
00709078002595
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 | 746 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 320 |