Duns Number:948904735
Device Description: 12" Microbore Extension Set - Sterile
Catalog Number
-
Brand Name
Custom Medical Specialties, Inc.
Version/Model Number
CMS-117
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
-
Product Code
GAZ
Product Code Name
Tubing, Noninvasive
Public Device Record Key
32dce8dc-b626-4d6f-a0ae-7e259cff928f
Public Version Date
February 19, 2021
Public Version Number
3
DI Record Publish Date
December 07, 2016
Package DI Number
00815849021365
Quantity per Package
50
Contains DI Package
00815849021358
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 |