Duns Number:801895244
Device Description: Extra-Large Accessory Pack
Catalog Number
-
Brand Name
Inca
Version/Model Number
44-2004
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
K911780,K911780
Product Code
BZD
Product Code Name
Ventilator, Non-Continuous (Respirator)
Public Device Record Key
1d823276-2b7e-484f-a9ac-bbaae2066d02
Public Version Date
March 22, 2022
Public Version Number
4
DI Record Publish Date
July 08, 2016
Package DI Number
20888937009563
Quantity per Package
4
Contains DI Package
60888937009561
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 | 29 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1471 |
| 3 | A medical device with high risk that requires premarket approval | 2 |