Duns Number:025460908
Device Description: BLOOD COLLECTION KIT
Catalog Number
DYNDM1071G
Brand Name
Medline Industries, Inc.
Version/Model Number
DYNDM1071G
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K121908,K121908
Product Code
FMI
Product Code Name
Needle, hypodermic, single lumen
Public Device Record Key
2567fc39-8aec-41de-b92a-afa528e9763e
Public Version Date
June 17, 2022
Public Version Number
3
DI Record Publish Date
February 07, 2021
Package DI Number
40193489435703
Quantity per Package
40
Contains DI Package
10193489435702
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 |