Duns Number:961027315
Device Description: GentleHeel
Catalog Number
GHP5X200
Brand Name
CARDINAL HEALTH
Version/Model Number
GHP5X200
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K172712,K172712,K172712
Product Code
FMK
Product Code Name
Lancet, blood
Public Device Record Key
73e60fe2-13de-4b52-b3de-f98f9cbdff9b
Public Version Date
May 08, 2019
Public Version Number
1
DI Record Publish Date
April 30, 2019
Package DI Number
20885380024693
Quantity per Package
200
Contains DI Package
00885380024699
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |