Duns Number:005083209
Device Description: SINGLE NEEDLE EXPANSION CHAMBER
Catalog Number
101739
Brand Name
BLOOD CIRCUIT SET
Version/Model Number
101739
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
K201809,K201809
Product Code
FJK
Product Code Name
Set, tubing, blood, with and without anti-regurgitation valve
Public Device Record Key
25174559-b20b-4e10-b61a-d6daec9945fd
Public Version Date
October 11, 2022
Public Version Number
2
DI Record Publish Date
May 13, 2021
Package DI Number
37332414004096
Quantity per Package
32
Contains DI Package
07332414004095
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 | 16 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |