Duns Number:964569052
Device Description: PLUS 30 PRIORITY PACK Accessory Kit INDEFLATOR PLUS 30 Inflation Device 30 atm 10 cc / Rot PLUS 30 PRIORITY PACK Accessory Kit INDEFLATOR PLUS 30 Inflation Device 30 atm 10 cc / Rotating Hemostatic Valve .115 " / Guide Wire Introducer / Torque Device
Catalog Number
1000185-115
Brand Name
Indeflator
Version/Model Number
1000185-115
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
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
-
Product Code
MAV
Product Code Name
Syringe, balloon inflation
Public Device Record Key
13c2f766-dc8d-4812-8ceb-d3c3ec8c1d87
Public Version Date
May 06, 2020
Public Version Number
4
DI Record Publish Date
August 05, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 964 |
| 3 | A medical device with high risk that requires premarket approval | 775 |