Duns Number:005083209
Device Description: Connector, Luer Lock-to-Luer Slip
Catalog Number
H93813701
Brand Name
RAPIDFILL
Version/Model Number
H93813701
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K872743,K872743
Product Code
FMF
Product Code Name
Syringe, piston
Public Device Record Key
84ac7bd9-35ae-4b12-842b-0425558f23c2
Public Version Date
June 09, 2021
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
50085412478321
Quantity per Package
50
Contains DI Package
00085412478326
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| 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. | 101 |
| 3 | A medical device with high risk that requires premarket approval | 19 |