FDA.reportPublic FDA data

MEDICAL ACTION INDUSTRIES

Primary DI
10809160201503
Brand
MEDICAL ACTION INDUSTRIES
Company
MEDICAL ACTION INDUSTRIES INC.
Model
78361
Published
2018-07-27
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PPABladder irrigation kit

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PPABladder Irrigation KitGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20809160201500PackageGS110Not in Commercial Distribution
10809160201503PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916020150020809160201500
1080916020150310809160201503

GMDN Terms#

Term, Definition table
TermDefinition
Bladder irrigation kitA collection of sterile devices designed for the infusion of fluids used to flush and evacuate the bladder of urine and other particulate matter. It typically includes tubing, connectors, a syringe, a roller clamp and other items used to flush the bladder. It may also be indicated for use in such procedures as a cystoscopy or a transurethral resection (TUR) as a means of continuous bladder irrigation. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Special Storage Condition, Specify00STORE AT ROOM TEMPERATURE

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10809160522790Medical Action Industries851072026-06-05
10809160522806Medical Action Industries851642026-06-05
10809160522479Medical Action Industries848692026-06-03
10809160521748MEDICAL ACTION INDUSTRIES849572026-05-22
10809160433560Medical Action Industries838852024-08-23
10809160278833Medical Action Industries78898D2020-02-21
10809160107270MEDICAL ACTION INDUSTRIES807792016-09-27
10809160188736Medical Action Industries781402018-04-13
10809160220733Medical Action Industries78521B2018-12-11
10809160272022Medical Action Industries789572019-11-21
10809160521410MEDICAL ACTION INDUSTRIES848532026-05-15
10809160521427MEDICAL ACTION INDUSTRIES848572026-05-15
10809160521434MEDICAL ACTION INDUSTRIES81183F2026-05-15
10809160521441Medical Action Industries81183E2026-05-15
10809160168493Medical Action Industries76828B2017-10-27
10809160520925MEDICAL ACTION INDUSTRIES847172026-05-11
10809160345108Medical Action Industries80391B2021-02-05
10809160429389Medical Action Industries840862024-07-10
10809160520635Medical Action Industries83349B2026-05-07
10809160520468Medical Action Industries771202026-05-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160429372Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
20809160429379Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.PPA2024-07-09
10809160372982MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
20809160372989MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2022-06-10
10195594345419CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
50195594345417CARDINAL HEALTHCardinal Health 200, LLCPPA2021-10-12
10195594277345CARDINAL HEALTHCardinal Health 200, LLCPPA2021-08-20
50195594277343CARDINAL HEALTHCardinal Health 200, LLCPPA2021-08-20
00616784426624Irrigation Tray with 60cc Bulb SyringesDynarex CorporationPPA2021-06-21
00616784426822Irrigation Tray with 60cc Piston SyringeDynarex CorporationPPA2021-06-21
10195594963880CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
50195594963888CARDINAL HEALTHCardinal Health 200, LLCPPA2021-05-03
10194717102281Regard™ROI CPS, LLCPPA2020-01-03
20194717102288Regard™ROI CPS, LLCPPA2020-01-03
10194717102298Regard™ROI CPS, LLCPPA2019-11-21
20194717102295Regard™ROI CPS, LLCPPA2019-11-21
10194717102304Regard™ROI CPS, LLCPPA2019-10-28
20194717102301Regard™ROI CPS, LLCPPA2019-10-28
20809160201500MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
10326053113045Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053113052Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113042Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
20326053113059Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-04-20
10326053112970Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16
20326053112977Regard™RESOURCE OPTIMIZATION & INNOVATION, L.L.C.PPA2017-02-16