Duns Number:632707092
Device Description: Following Device Identifiers are included in this KIT:07325710004128,07325710004104
Catalog Number
-
Brand Name
Volu.reflec, incl.Reflector socket
Version/Model Number
6680327
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K133958,K191027
Product Code
BSZ
Product Code Name
Gas-Machine, Anesthesia
Public Device Record Key
13f49094-b4cb-4275-a44e-dcbf8ab640f0
Public Version Date
April 07, 2020
Public Version Number
4
DI Record Publish Date
October 23, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
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 |