FDA.reportPublic FDA data

MD Resource

Primary DI
60859898006241
Brand
MD Resource
Company
MEDICAL DEVICE RESOURCE CORPORATION
Model
AV1200D
Catalog number
AV1200D
Device description
Aquavage 1200cc
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
10859898006246PackageGS12In Commercial Distribution
20859898006243PackageGS13In Commercial Distribution
30859898006240PackageGS14In Commercial Distribution
40859898006247PackageGS15In Commercial Distribution
50859898006244PackageGS16In Commercial Distribution
60859898006241PackageGS110In Commercial Distribution
00859898006249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085989800624610859898006246
2085989800624320859898006243
3085989800624030859898006240
4085989800624740859898006247
5085989800624450859898006244
6085989800624160859898006241
00859898006249008598980062498598980062490859898006249

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 Humidity15 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature25 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature77 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
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
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