Duns Number:480797856
Device Description: Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Attachment Standard Starter Set (without Service Gas) contains:Ear Clips (EC-MI)Multi-Site Attachment Rings for mature/intact skin (MAR-MI)Multi-Site Attachment Rings for sensitive/fragile skin (MAR-SF)Membrane Changer tool (reloadable) (MC-R)Contact Gel (GEL-04)
Catalog Number
-
Brand Name
Standard Starter Set (without Service Gas)
Version/Model Number
SSET_nG
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
K041548,K071672,K101690,K151329
Product Code
DPZ
Product Code Name
Oximeter, Ear
Public Device Record Key
1790f7e3-d6a5-4475-ac27-a30e261bc2db
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
August 31, 2016
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 38 |