Duns Number:012430880
Device Description: PRIMARY ADMINISTRATION SET
Catalog Number
5700885
Brand Name
Henry Schein
Version/Model Number
5700885
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
K101958,K101958
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
4c044fd1-14b9-446f-81d8-9a4bfe8c848f
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
April 30, 2018
Package DI Number
10304040070922
Quantity per Package
50
Contains DI Package
00304040070925
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 | 3829 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2579 |
| 3 | A medical device with high risk that requires premarket approval | 1 |
| U | Unclassified | 34 |