Duns Number:324869601
Device Description: Acceesory KIT for Manual Suction Pump
Catalog Number
n.a.
Brand Name
n.a.
Version/Model Number
30-56-000
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
1d5b25ce-3405-43b0-bfc0-f48915817a1e
Public Version Date
May 12, 2021
Public Version Number
1
DI Record Publish Date
May 04, 2021
Package DI Number
14250105628767
Quantity per Package
1
Contains DI Package
04250105628760
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 | 334 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |