DEVICE: Du-O-Vac (00856438007407)
Notice: Any discrepancies with this record compared to the label?
If so, send a picture of the label to
GUDIDSupport@fda.hhs.gov.
Device Identifier (DI) Information
Du-O-Vac
DV-5242
In Commercial Distribution
W. T. FARLEY, INC.
DV-5242
In Commercial Distribution
W. T. FARLEY, INC.
Emergency Venturi Suction Device
Device Characteristics
| MR Unsafe | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No | |
| No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
| GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
|---|---|---|---|---|
| 47367 | Emergency airway clearance suction system, pneumatic |
A portable assembly of devices, which includes a non-surgical invasive component, intended to aspirate unwanted materials (e.g., fluids, secretions) from the airway typically during patient transport or an emergency situation (e.g., placed on a crash cart), by means of suction generated from a compressed gas supply (the Venturi principle). It includes a pneumatic suction regulator which controls the degree of negative pressure for aspiration, a portable supply of compressed gas (e.g., cylinder of air or oxygen), collection containers, tubing, microbial/hydrophobic filters, and patient contact devices (e.g., handpiece/tip, mask).
|
Active | false |
FDA Product Code
[?]| Product Code | Product Code Name |
|---|---|
| GCX | APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED |
FDA Premarket Submission
| FDA Premarket Submission Number [?] | Supplement Number [?] |
|---|---|
| K781988 | 000 |
Sterilization
Storage and Handling
[?]| Storage and Handling |
|---|
| No storage/handling found |
Clinically Relevant Size
[?]| Size Type Text |
|---|
| Pressure: 50 Pound per Square Inch |
| Device Size Text, specify: Du-O-Vac plus Pediatric with Puritan Bennett QC and 8 collection bottles |
Device Record Status
f7470a5b-5934-4200-b5df-23e50780e8a8
August 23, 2018
4
June 14, 2017
August 23, 2018
4
June 14, 2017
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]| Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
|---|---|---|---|---|---|
| No Package DIs found | |||||
Secondary DI
[?]| Issuing Agency [?] | Secondary DI Number |
|---|---|
| No Secondary DIs found | |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined