Duns Number:071595540
Device Description: Replacement filter for Berchtold TeleVac and TeleVac LT
Catalog Number
BTLD004
Brand Name
OR-VAC
Version/Model Number
BTLD004
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FYD
Product Code Name
APPARATUS, EXHAUST, SURGICAL
Public Device Record Key
5e60cd72-2923-49de-8178-d611ac7a0d53
Public Version Date
April 22, 2022
Public Version Number
2
DI Record Publish Date
July 16, 2020
Package DI Number
30845854081932
Quantity per Package
4
Contains DI Package
20845854081935
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 |