FDA.reportPublic FDA data

MD Resource

Primary DI
00859898006409
Brand
MD Resource
Company
MEDICAL DEVICE RESOURCE CORPORATION
Model
AV2000D
Catalog number
AV2000D
Device description
Aquavage 2000cc
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)
MUUSystem, Suction, Lipoplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1
MUUSystem, Suction, LipoplastyGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092284000LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200Medical Device Resource Corp.2009-09-01MUU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20859898006403PackageGS12In Commercial Distribution
30859898006400PackageGS13In Commercial Distribution
40859898006407PackageGS14In Commercial Distribution
50859898006404PackageGS15In Commercial Distribution
60859898006401PackageGS16In Commercial Distribution
70859898006408PackageGS110In Commercial Distribution
00859898006409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085989800640320859898006403
3085989800640030859898006400
4085989800640740859898006407
5085989800640450859898006404
6085989800640160859898006401
7085989800640870859898006408
00859898006409008598980064098598980064090859898006409

GMDN Terms#

Term, Definition table
TermDefinition
Surgical suction system collection container, single-useA sealable container (e.g., cylindrical, bottle-shaped, pouch) intended to be used as a component of a surgical suction system to collect aspirated materials (e.g., blood/bodily fluids, gases, body tissues, calculi) from a surgical site for disposal (e.g., to prevent backflow) or diagnostic/therapeutic purposes (e.g., tissue or 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
510-732-9950sales@mdresource.com

Regulatory Flags#

DUNS number
126830020
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859898006249MD ResourceAV1200DAV1200D2016-09-08
00859898006386MD ResourceLS7020LS70202016-10-31
00859898006096MD ResourceLS7030LS70302016-08-30
00859898006423MD ResourceK PumpK Pump2016-09-08
00859898006430MD ResourceBPIBPI2016-09-08
00859898006003MD ResourceLS7010LS70102016-08-30
00859898006119MD ResourceLS7012LS70122016-08-30
60859898006241MD ResourceAV1200DAV1200D2016-09-08
10859898006383MD ResourceLS7020LS70202016-10-31
70859898006408MD ResourceAV2000DAV2000D2016-09-08
00859898006140MD ResourceLS7010LS70102016-08-30
00859898006133MD ResourceLS7012LS70122016-08-30
00859898006508MD ResourceFL3000M2019-09-11
00859898006492MD ResourceFL30002019-09-11
10859898006505MD ResourceFL3000M2019-09-11
00859898006256MD ResourceLS2-DPLS2-DP2016-09-23
00859898006379MD ResourceLS2-DLSLS2-DLS2016-09-23
00859898006416MD ResourceLS2LS22016-09-08
00859898006454MD ResourceRM2000RM20002016-09-13
00859898006027MD ResourceAFTDAFTD2016-08-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956466579CARDINAL HEALTHCardinal Health 200, LLCKYZ2026-05-19
10653160392859Medline Industries, Inc.MEDLINE INDUSTRIES, INC.KYZ2026-04-08
10192253068856MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253068863MonojectCardinal Health 200, LLCKYZ2026-01-29
10192253007442MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007480MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007510MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007534MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007558MonojectCardinal Health 200, LLCKYZ2025-12-15
10192253007732MonojectCardinal Health 200, LLCKYZ2025-12-15
10198956204768CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-10
10198956194649CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-09-08
10198956181540CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-08-14
10704411006152AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007074AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
10704411007098AMSure® Enteral Feeding Thumb Control Ring Syringe with ENFit™ TipAMSINO INTERNATIONAL, INC.KYZ2025-06-24
08800052308909FPU(Fat Processing Unit)Medikan Co., Ltd.MUU2025-05-20
10198956080706CARDINAL HEALTHCardinal Health 200, LLCKYZ2025-05-07
10192253028775DoverCardinal Health 200, LLCKYZ2025-04-10
10192253028805DoverCardinal Health 200, LLCKYZ2025-04-10
10192253028829DoverCardinal Health 200, LLCKYZ2025-04-10
10192253028768DoverCardinal Health 200, LLCKYZ2025-02-14
10192253028799DoverCardinal Health 200, LLCKYZ2025-02-14
10192253010916KangarooCardinal Health 200, LLCKYZ2025-02-04
10192253011043KangarooCardinal Health 200, LLCKYZ2024-12-03
10192253010930KangarooCardinal Health 200, LLCKYZ2024-12-02
10197106821299CARDINAL HEALTHCardinal Health 200, LLCKYZ2024-10-25
10197106810491CARDINAL HEALTHCardinal Health 200, LLCKYZ2024-10-23
10197106745755CARDINAL HEALTHCardinal Health 200, LLCKYZ2024-08-12
10197106702444CARDINAL HEALTHCardinal Health 200, LLCKYZ2024-06-21