Duns Number:006261481
Device Description: PROBE CB4627 BIOACT FLOW PED 10PK
Catalog Number
-
Brand Name
Bio-Probe™
Version/Model Number
CB4627
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)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K132730,K132730
Product Code
DPT
Product Code Name
PROBE, BLOOD-FLOW, EXTRAVASCULAR
Public Device Record Key
a9ac0f1a-3cb9-456a-884b-750595bebe19
Public Version Date
September 27, 2021
Public Version Number
1
DI Record Publish Date
September 18, 2021
Package DI Number
20763000419909
Quantity per Package
10
Contains DI Package
00763000419905
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PK
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |