Duns Number:007941230
Device Description: Solution Respiratory 9 Percent Sodium Chloride Convenient Twist-Off Cap 5 Milliliter Steri Solution Respiratory 9 Percent Sodium Chloride Convenient Twist-Off Cap 5 Milliliter Sterile Not Made With Natural Rubber Latex MediChoice
Catalog Number
-
Brand Name
MediChoice
Version/Model Number
UD9005
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
K820227,K820227,K820227
Product Code
CAF
Product Code Name
NEBULIZER (DIRECT PATIENT INTERFACE)
Public Device Record Key
03222c6c-984e-4e5d-8f5f-fbd16dd9b3f5
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 28, 2016
Package DI Number
50885632127630
Quantity per Package
10
Contains DI Package
30885632127636
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 |