Duns Number:038000253
Device Description: 12.5F X 32CM HEMO-CATH® LT SILICONE DOUBLE LUMENLT SILIC BASIC SETBASIC SET (CUFF 27CM FRO 12.5F X 32CM HEMO-CATH® LT SILICONE DOUBLE LUMENLT SILIC BASIC SETBASIC SET (CUFF 27CM FROM TIP)(CUFF 27CM F
Catalog Number
DSL32
Brand Name
HEMO-CATH®
Version/Model Number
DSL32
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
-
Product Code
LFJ
Product Code Name
CATHETER, SUBCLAVIAN
Public Device Record Key
adf06e70-0239-4151-91cc-196c580003cb
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
June 27, 2019
Package DI Number
50884908140878
Quantity per Package
5
Contains DI Package
00884908140873
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2560 |