Duns Number:005083209
Device Description: UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container o UltraClamp Tubing is designed to facilitate clamping of tubing on the UltraBag Container or any Baxter Y-Set. The clamp is specifically designed to assist individuals who experience difficulty in operating other ancillary clamps or pre-attached clamps.
Catalog Number
5C4957
Brand Name
ULTRACLAMP
Version/Model Number
5C4957
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
-
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
FKK
Product Code Name
CLAMP, LINE
Public Device Record Key
df6df18f-789a-4b3a-8ea4-0303164e5c78
Public Version Date
June 05, 2020
Public Version Number
2
DI Record Publish Date
March 15, 2019
Package DI Number
50085412070648
Quantity per Package
12
Contains DI Package
00085412070643
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 |