Duns Number:071595540
Device Description: 7/8 in (22mm) x 10 ft (3.1m) with 8 in (20cm) integral wand and sponge guard
Catalog Number
OL3MT24
Brand Name
OR-VAC
Version/Model Number
OL3MT24
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
-
Product Code
GAZ
Product Code Name
TUBING, NONINVASIVE
Public Device Record Key
0cef2614-9b0c-4bdd-bb7f-67bec2989e7f
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
July 21, 2020
Package DI Number
30845854061859
Quantity per Package
24
Contains DI Package
20845854061852
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |