FDA.reportPublic FDA data

Du-O-Vac

Primary DI
00856438007100
Brand
Du-O-Vac
Company
W. T. FARLEY, INC.
Model
DV-510A
Device description
Emergency Venturi Suction Device
Published
2017-06-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
GCXAPPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K781988000

Premarket Details#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856438007100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856438007100008564380071008564380071000856438007100

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Pressure50Pound per Square Inch

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
063805113
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10856438007916Du-O-Vac CanisterDV-3-1102017-06-14
00856438007926CS-ARMCS-ARM2020-06-24
00856438007933CS-ARMCS-ARM-22020-06-24
00856438007940CS-ARMCS-ARM-32020-06-24
00856438007957CS-ARMCS-ARM12020-06-24
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
00856438007117Du-O-VacDV-51102017-06-14
00856438007124Du-O-VacDV-51122017-06-14
00856438007131Du-O-VacDV-51202017-06-14
00856438007148Du-O-VacDV-51222017-06-14
00856438007155Du-O-VacDV-512C2017-06-14

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Primary DI, Brand, Company table
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