Duns Number:025460908
Device Description: KIT,2000CC CANISTER,3/16"X6' TUBING
Catalog Number
OR320
Brand Name
MEDLINE INDUSTRIES, INC.
Version/Model Number
OR320
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)
Yes
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
f588fc34-0836-442b-8f5c-d45b2380a146
Public Version Date
October 24, 2022
Public Version Number
2
DI Record Publish Date
December 16, 2021
Package DI Number
20888277638287
Quantity per Package
30
Contains DI Package
10888277638280
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 |