FDA.report

Du-O-Vac

Primary DI
00856438007872
Brand
Du-O-Vac
Company
W. T. FARLEY, INC.
Model
MRI-DV-CODE2
Device description
Emergency Venturi Suction Device
Published
2017-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications

CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K781988000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K781988000SUCTION APPARATUS, POWERED BY COMP. AIRFarley, W.T.1978-12-12GCX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00856438007872PrimaryGS10

GMDN Terms

TermDefinition
Emergency airway clearance suction system, pneumaticA 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).

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
063805113
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00856438007926CS-ARMCS-ARM2020-06-24
00856438007933CS-ARMCS-ARM-22020-06-24
00856438007940CS-ARMCS-ARM-32020-06-24
00856438007957CS-ARMCS-ARM12020-06-24
10856438007916Du-O-Vac CanisterDV-3-1102017-06-14
00856438007001Du-O-VacDV-51002017-06-14
00856438007018Du-O-VacDV-51012017-06-14
00856438007025Du-O-VacDV-51022017-06-14
00856438007032Du-O-VacDV-51032017-06-14
00856438007049Du-O-VacDV-51042017-06-14
00856438007056Du-O-VacDV-51052017-06-14
00856438007063Du-O-VacDV-51062017-06-14
00856438007070Du-O-VacDV-51072017-06-14
00856438007087Du-O-VacDV-51082017-06-14
00856438007094Du-O-VacDV-51092017-06-14
00856438007100Du-O-VacDV-510A2017-06-14
00856438007117Du-O-VacDV-51102017-06-14
00856438007124Du-O-VacDV-51122017-06-14
00856438007131Du-O-VacDV-51202017-06-14
00856438007148Du-O-VacDV-51222017-06-14

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00653405014952POOLEConmed CorporationGCX2026-03-24
50198956355475CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-19
50198956417999CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
G8057116571Bleed IDAPARATA MEDICAL, LLCGCX2026-03-02
50198956375640CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
50198956277937CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
20889483228743Muc-Away™SUNMED, LLCGCX2025-12-31
20889483228750Muc-Away™SUNMED, LLCGCX2025-12-31
20889483230111Muc-Away™SUNMED, LLCGCX2025-12-31
10889483230121Muc-Away™SUNMED, LLCGCX2025-12-31
50198956261806CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
50192253043363CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043370CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043387CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043394CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043400CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50192253043417CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
50198956252125CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
20816286021189Boehringer Surgical Suction DeviceBOEHRINGER LABORATORIES, LLCGCX2025-11-24
50198956160857CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
50198956180381CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
00194613008253MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019945MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613019952MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021504MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021511MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021627MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021634MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021641MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01
00194613021665MSI Precision Specialty InstrumentsMed Saver, Inc.GCX2025-08-01