Duns Number:025460908
Device Description: TEST,HCG,PREGNANCY,URINE,STRIP,25 MIU
Catalog Number
MPH11025HCG
Brand Name
Medline
Version/Model Number
MPH11025HCG
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
JHI
Product Code Name
Visual, pregnancy hCG, prescription use
Public Device Record Key
7cf22916-cc49-4001-83cb-a47b05e4a325
Public Version Date
February 24, 2021
Public Version Number
3
DI Record Publish Date
October 14, 2016
Package DI Number
30884389191877
Quantity per Package
25
Contains DI Package
10884389191873
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 | 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 |