Duns Number:025460908
Device Description: CC ADULT DRAWER 1
Catalog Number
ACC010255B
Brand Name
Medline Industries, Inc.
Version/Model Number
ACC010255B
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"
-
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
K965132,K965132
Product Code
BTR
Product Code Name
Tube, tracheal (w/wo connector)
Public Device Record Key
ccb33711-b267-462b-9ad9-05f5c1624f90
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
September 28, 2016
Package DI Number
40889942274513
Quantity per Package
6
Contains DI Package
10889942274512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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 |