Duns Number:025460908
Device Description: HOLDER,TRACH TUBE,PEDIATRIC
Catalog Number
ZPP301P
Brand Name
Medline
Version/Model Number
ZPP301P
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)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
CBH
Product Code Name
DEVICE, FIXATION, TRACHEAL TUBE
Public Device Record Key
c855ab6e-356a-4fb5-931e-bfab9326f73a
Public Version Date
September 22, 2021
Public Version Number
1
DI Record Publish Date
September 14, 2021
Package DI Number
40080196804215
Quantity per Package
20
Contains DI Package
10080196804214
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 | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |