Duns Number:948904735
Device Description: Large Bore Infiltration Set - Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties
Version/Model Number
CMS-1213
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
K993463,K993463
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
9472369c-6ad3-480b-baae-45d7a6a0c54e
Public Version Date
July 19, 2021
Public Version Number
4
DI Record Publish Date
September 25, 2019
Package DI Number
00815849023277
Quantity per Package
10
Contains DI Package
00815849023253
Package Discontinue Date
-
Package Status
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 | 78 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 72 |