Duns Number:042823948
Device Description: Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set
Catalog Number
C-PTIS-100-HC-G-EU-EVAC7.5
Brand Name
Blue Rhino
Version/Model Number
G57697
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 13, 2022
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
K193133
Product Code
JOH
Product Code Name
Tube tracheostomy and tube cuff
Public Device Record Key
aa4e7e9f-7ada-4374-8712-5a4a0b4508ee
Public Version Date
May 16, 2022
Public Version Number
2
DI Record Publish Date
July 27, 2020
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 | 669 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8328 |
| 3 | A medical device with high risk that requires premarket approval | 370 |
| U | Unclassified | 242 |