Duns Number:025460908
Device Description: KIT, SEMI, 1500CC, TUBING 10' X 1/4"
Catalog Number
OR529K
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
OR529K
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
-
Product Code
KDQ
Product Code Name
BOTTLE, COLLECTION, VACUUM
Public Device Record Key
f8aae626-c283-4f5e-b92b-c127f79f5161
Public Version Date
August 05, 2022
Public Version Number
2
DI Record Publish Date
December 31, 2020
Package DI Number
40888277253101
Quantity per Package
72
Contains DI Package
10888277253100
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 |