FDA.reportPublic FDA data

MD Resource

Primary DI
70859898006408
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KYZSyringe, Irrigating (Non Dental)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KYZSyringe, Irrigating (Non Dental)General Hospital1

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 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.

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
126830020
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859898006249MD ResourceAV1200DAV1200D2016-09-08
00859898006386MD ResourceLS7020LS70202016-10-31
00859898006409MD ResourceAV2000DAV2000D2016-09-08
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
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
20192253068884MonojectCardinal Health 200, LLCKYZ2026-01-29
20192253068891MonojectCardinal 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
00661392004474LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392007437LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010734LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392010758LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055124LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
00661392055155LSL HEALTHCARELSL Industries, LLCKYZ2025-10-30
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
00661392002258LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002265LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002845LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002852LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392002920LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16
00661392004443LSL HEALTHCARELSL Industries, LLCKYZ2025-05-16