Duns Number:825673239
Device Description: RECEPTAL™Suction Procedure KitEZE-VAC® Disposable Canister with lid, elbows on patient and RECEPTAL™Suction Procedure KitEZE-VAC® Disposable Canister with lid, elbows on patient and vacuum portNon-sterile suction tube 3/16 in. ID × 6 ft. (5 mm × 1.8 m) with connnectorsNon-sterile suction tube 3/16 in. ID × 18 ft. (5 mm × 46 cm) with connnectors
Catalog Number
ELID2-820821
Brand Name
RECEPTAL™ Suction Procedure Kit
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
KDQ
Product Code Name
Bottle, Collection, Vacuum
Public Device Record Key
0886390a-6da3-492a-b5d0-e827ee5f7cea
Public Version Date
November 19, 2019
Public Version Number
1
DI Record Publish Date
November 11, 2019
Package DI Number
40704411011539
Quantity per Package
30
Contains DI Package
10704411011521
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 |