Duns Number:001061233
Device Description: Dale Nasogastric Tube Holder, Large/Adult
Catalog Number
160
Brand Name
Dale Nasogastric Tube Holder
Version/Model Number
160
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KGX
Product Code Name
Tape And Bandage, Adhesive
Public Device Record Key
f3293864-0473-4291-b59f-53109bd0f092
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
August 29, 2018
Package DI Number
H84101602
Quantity per Package
50
Contains DI Package
H84101601
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 74 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |