Duns Number:316153865
Device Description: Venous Return Catheter reinf. 36 F., straight, 9cm lumen-tip, sterile, no coating, single Venous Return Catheter reinf. 36 F., straight, 9cm lumen-tip, sterile, no coating, single packed for clinical use.
Catalog Number
70102.3938
Brand Name
Maquet Venous Return Catheter
Version/Model Number
620369
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 31, 2020
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
K872182,K872182
Product Code
DQY
Product Code Name
CATHETER, PERCUTANEOUS
Public Device Record Key
2b186824-2016-453d-a52b-0734fb43080a
Public Version Date
August 05, 2022
Public Version Number
6
DI Record Publish Date
March 27, 2017
Package DI Number
04037691016092
Quantity per Package
10
Contains DI Package
04037691237619
Package Discontinue Date
January 31, 2020
Package Status
Not in Commercial Distribution
Package Type
-
| 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. | 286 |