Duns Number:080361159
Device Description: TUBING OXYGEN 7FT CRUSH RESISTANT-W/UNIVERSAL CONNECTOR (MALE AND FEMALE), 1/EA
Catalog Number
-
Brand Name
TIGER MEDICAL
Version/Model Number
RTT157
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)
Yes
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
BYX
Product Code Name
Tubing, Pressure And Accessories
Public Device Record Key
cfdf92f5-05b5-4b46-9ce0-703b6d7f77c2
Public Version Date
August 08, 2022
Public Version Number
1
DI Record Publish Date
July 31, 2022
Package DI Number
10840216101576
Quantity per Package
50
Contains DI Package
00840216101579
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1046 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |
| U | Unclassified | 2 |