Duns Number:025460908
Device Description: PEDIATRIC BLOOD CULTURE KIT
Catalog Number
DYNDH1363
Brand Name
MEDLINE
Version/Model Number
DYNDH1363
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OIB
Product Code Name
Blood and urine collection kit (excludes HIV testing)
Public Device Record Key
6e9e3382-16c6-4506-bbf6-4b7f4a0237f8
Public Version Date
August 27, 2020
Public Version Number
1
DI Record Publish Date
August 19, 2020
Package DI Number
40888277795465
Quantity per Package
20
Contains DI Package
10888277795464
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 |