Duns Number:827221698
Device Description: Full Arm Single Chamber Sleeve, Medium
Catalog Number
-
Brand Name
Meridian Medical
Version/Model Number
SLV-FAM
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"
-
For Single-Use
-
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
K974393,K974393
Product Code
JOW
Product Code Name
Sleeve, Limb, Compressible
Public Device Record Key
94a293e4-fa8f-4d21-9494-f893d427d665
Public Version Date
August 03, 2020
Public Version Number
2
DI Record Publish Date
April 17, 2019
Package DI Number
30815067043867
Quantity per Package
10
Contains DI Package
00815067043866
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 | 62 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 273 |
| U | Unclassified | 2 |