Duns Number:042823948
Device Description: Spectrum CVC Hyperalimentation Set Minocycline/Rifampin Antibiotic Impregnated Triple Lume Spectrum CVC Hyperalimentation Set Minocycline/Rifampin Antibiotic Impregnated Triple Lumen Silicone
Catalog Number
HASTC-8.0-ABRM
Brand Name
Cook Spectrum
Version/Model Number
G51200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 02, 2022
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
LJS
Product Code Name
Catheter,intravascular,therapeutic,long-term greater than 30 days
Public Device Record Key
725bbb07-4bf5-4faa-9d30-42854d0c5585
Public Version Date
February 03, 2022
Public Version Number
5
DI Record Publish Date
October 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |