Duns Number:825673239
Device Description: AMSafe® Standardbore Extension Set100 inch long (254cm)CAUTION: Avoid freezing and excessi AMSafe® Standardbore Extension Set100 inch long (254cm)CAUTION: Avoid freezing and excessive heat.
Catalog Number
IVE2500
Brand Name
AMSafe® Standardbore Extension Set
Version/Model Number
1
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
K093773,K093773
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
7c176865-1964-484b-9470-1e73f3911af0
Public Version Date
April 07, 2021
Public Version Number
2
DI Record Publish Date
April 17, 2020
Package DI Number
40704411012178
Quantity per Package
50
Contains DI Package
10704411012177
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |