FDA.report

Du-O-Vac Canister

Primary DI
10856438007916
Brand
Du-O-Vac Canister
Company
W. T. FARLEY, INC.
Model
DV-3-110
Device description
Collection Canister for Du-O-Vac, 10 Pack
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
true

Related Records

Product Codes

CodeName
KDQBOTTLE, COLLECTION, VACUUM

Product Code Classifications

CodeDeviceSpecialtyClass
KDQBottle, Collection, VacuumGeneral 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
10856438007916PrimaryGS10
00856438007919Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085643800791610856438007916
00856438007919008564380079198564380079190856438007919

GMDN Terms

TermDefinition
Surgical suction system collection container, single-useA cylindrical or bottle-shaped sealable container intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., polyp trap). It may be used singularly or connected in a series to provide greater capacity, and may be graduated to facilitate determination of the quantity of its contents; it may also be used in conjunction with aspiration liners and may include lid, microbial/hydrophobic filters or tubing. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
063805113
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
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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
00856438007155Du-O-VacDV-512C2017-06-14

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