Duns Number:401966697
Device Description: GAS SAMPLING LINE, DISPOSABLE, PVC/PE, 6M/20FT, 1 PCS
Catalog Number
-
Brand Name
NA
Version/Model Number
2097307-003
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BZK
Product Code Name
Spirometer, monitoring (w/wo alarm)
Public Device Record Key
81e047cc-924c-4460-baf4-c7344ea789cd
Public Version Date
August 05, 2022
Public Version Number
8
DI Record Publish Date
March 20, 2017
Package DI Number
20840682120689
Quantity per Package
5
Contains DI Package
00840682120685
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 224 |