Duns Number:057827420
Device Description: EXTENSION LINES
Catalog Number
-
Brand Name
HAEMONETICS R.I.S. SYSTEM
Version/Model Number
00401-00
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
K852645,K852645,K852645
Product Code
FRN
Product Code Name
Pump, Infusion
Public Device Record Key
604600e2-d04c-4bf1-b9aa-038b245dbb01
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
30812747016227
Quantity per Package
20
Contains DI Package
20812747016220
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 4 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 158 |
| U | Unclassified | 2 |