Duns Number:016898496
Device Description: ReliaVac 400 Closed Wound Suction Kit, Medium 1/8" (10Fr., 3.2mm) O.D. PVC Drain, 12.5" Ho ReliaVac 400 Closed Wound Suction Kit, Medium 1/8" (10Fr., 3.2mm) O.D. PVC Drain, 12.5" Hole Pattern, X-Ray Opaque Stripe with Attached Trocar, 400cc Evacuator
Catalog Number
0034610
Brand Name
Closed Wound Suction
Version/Model Number
0034610
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GCY
Product Code Name
APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
Public Device Record Key
47d6cde7-874f-49e9-a9d3-7240d4295a3e
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
September 22, 2020
Package DI Number
20801741049129
Quantity per Package
2
Contains DI Package
10801741049122
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |