FDA.reportPublic FDA data

Medical Action Industries

Primary DI
20809160429379
Brand
Medical Action Industries
Company
MEDICAL ACTION INDUSTRIES INC.
Model
84085
Published
2024-07-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
20809160429379PackageGS120In Commercial Distribution
10809160429372PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2080916042937920809160429379
1080916042937210809160429372

GMDN Terms#

Term, Definition table
TermDefinition
Urological irrigation setA collection of sterile items intended to be used for the infusion of fluids used to flush the urethra and bladder. It typically includes tubing, connectors, a syringe, a roller clamp and other items used for flushing or continuous irrigation in procedures such as a cystoscopy or transurethral resection (TUR). 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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
092364462
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
true
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
true
Sterilization required before use
false

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
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
10809160201503MEDICAL ACTION INDUSTRIESMEDICAL ACTION INDUSTRIES INC.PPA2018-07-27
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