Duns Number:878263359
Device Description: multi-Collect Specimen Collection Kit
Catalog Number
9K12-04
Brand Name
Multi-Collect
Version/Model Number
9K12-04
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
K140354,K140354,K140354
Product Code
LIO
Product Code Name
DEVICE, SPECIMEN COLLECTION
Public Device Record Key
47c76d00-8b5e-48e2-b1fd-804a15cb9de7
Public Version Date
July 22, 2021
Public Version Number
8
DI Record Publish Date
September 01, 2016
Package DI Number
20884999046522
Quantity per Package
50
Contains DI Package
00884999046528
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 339 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 76 |
| 3 | A medical device with high risk that requires premarket approval | 36 |