Duns Number:080361159
Device Description: BAG, PRESSURE INFUSER, 500ML, MESH BACK, NON-MAGNETIC/MRI CONDITIONAL, 150 mm (W) x 289 mm BAG, PRESSURE INFUSER, 500ML, MESH BACK, NON-MAGNETIC/MRI CONDITIONAL, 150 mm (W) x 289 mm (H)
Catalog Number
-
Brand Name
ASP MEDICAL
Version/Model Number
IAMRC01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
Yes
Device labeled as "Not made with natural rubber latex"
-
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
KZD
Product Code Name
Infusor, Pressure, For I.V. Bags
Public Device Record Key
1db4780c-34f3-48a6-8dd4-1720f9958a41
Public Version Date
July 25, 2022
Public Version Number
1
DI Record Publish Date
July 15, 2022
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 | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |