Duns Number:053146767
Device Description: Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by securing ventil Ventilator Tubing Accessory - Safety Strap helps to prevent disconnects by securing ventilator circuit components.
Catalog Number
NP 105-1
Brand Name
NP 105-1 Safety Strap
Version/Model Number
NP 105-1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZO
Product Code Name
Set, Tubing And Support, Ventilator (W Harness)
Public Device Record Key
ac1215fa-33ea-4e41-ae6b-7cdd4fd4d1c2
Public Version Date
October 24, 2022
Public Version Number
3
DI Record Publish Date
April 26, 2019
Package DI Number
M996NP10512
Quantity per Package
10
Contains DI Package
M996NP10510
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Polybag
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |