Duns Number:324869601
Device Description: Connecting Tube for pressure or gas measuring
Catalog Number
-
Brand Name
n.a.
Version/Model Number
61-95-200
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 15, 2021
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"
Yes
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
BZA
Product Code Name
Connector, Airway (Extension)
Public Device Record Key
3b7afa08-7553-4357-b8d5-1b48d409d1c6
Public Version Date
September 16, 2021
Public Version Number
3
DI Record Publish Date
August 31, 2020
Package DI Number
14250105611318
Quantity per Package
10
Contains DI Package
04250105611311
Package Discontinue Date
September 15, 2021
Package Status
Not 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 |