Duns Number:632707092
Catalog Number
-
Brand Name
Gas sampling line 2.0m (M/M)
Version/Model Number
6693510
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
K133958,K133958
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
8db326e7-d62c-4b47-bb12-e70b5fd82386
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 30, 2015
Package DI Number
17325710002510
Quantity per Package
25
Contains DI Package
07325710002513
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 | 62 |
2 | A medical device with a moderate to high risk that requires special controls. | 131 |