Duns Number:041810693
Catalog Number
7001103
Brand Name
MPS® Extension Tubing, 6 ft. x 3/16 in.
Version/Model Number
7001103
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
K953838,K953838
Product Code
DTR
Product Code Name
Heat-Exchanger, Cardiopulmonary Bypass
Public Device Record Key
8e0f4b31-1833-4ab8-b45d-aec027c3dc2a
Public Version Date
October 19, 2021
Public Version Number
4
DI Record Publish Date
June 15, 2016
Package DI Number
20634624701131
Quantity per Package
10
Contains DI Package
00634624701137
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipper
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 22 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 168 |
| U | Unclassified | 8 |