Duns Number:825673239
Device Description: RECEPTAL™ 2000ML DISPOSABLE LINER2000ML LINER WITH VAC-GARD® AND 12 GRAM GERMICIDE
Catalog Number
0G661
Brand Name
RECEPTAL™ 2000ML DISPOSABLE LINER
Version/Model Number
1
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"
Yes
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
GCX
Product Code Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Public Device Record Key
948623ae-d462-4a1a-9898-5ed9d8d39ee1
Public Version Date
July 09, 2019
Public Version Number
2
DI Record Publish Date
June 29, 2019
Package DI Number
40704411007747
Quantity per Package
50
Contains DI Package
10704411007746
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 | 89 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 411 |
| U | Unclassified | 1 |