Duns Number:001061233
Device Description: Dale Nasogastric Tube Holder, Small / Young Adult / Pediatric / Geriatric
Catalog Number
161
Brand Name
Dale Nasogastric Tube Holder
Version/Model Number
161
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)
-
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
299aaea2-5a99-4147-ae4a-b86d15cda5ad
Public Version Date
July 22, 2019
Public Version Number
3
DI Record Publish Date
March 18, 2019
Package DI Number
00817612020636
Quantity per Package
50
Contains DI Package
00817612020629
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 |