Duns Number:025460908
Device Description: TUBE,ENDOTRACH,HVLP CUFF,MURPHY,8.5MM
Catalog Number
DYND43085
Brand Name
Medline Industries, Inc.
Version/Model Number
DYND43085
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
K042683,K042683
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
68a8fd04-133d-4a30-8008-48b48329a654
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
October 15, 2015
Package DI Number
30080196726343
Quantity per Package
10
Contains DI Package
10080196726349
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 | 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 |