Duns Number:002348191
Device Description: INNER TUBE #5 CLJ IMPROVED + 2 SHIKANI SPEAKING VA
Catalog Number
518032
Brand Name
PILLING
Version/Model Number
IPN008297
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
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
K982128,K982128,K982128
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
b5273e1e-dc65-4196-b344-34eba1cf4e0f
Public Version Date
October 29, 2020
Public Version Number
6
DI Record Publish Date
October 12, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |