FDA.reportPublic FDA data

Dynarex Corporation

Primary DI
16970754494862
Brand
Dynarex Corporation
Company
GCMEDICA ENTERPRISE LTD. (WUXI)
Model
GC1957R08
Published
2023-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCXApparatus, Suction, Operating-Room, Wall Vacuum PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
36970754494866PackageGS110In Commercial Distribution
16970754494862PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3697075449486636970754494866
1697075449486216970754494862

GMDN Terms#

Term, Definition table
TermDefinition
Suction system canister linerA device made of disposable materials used to cover the inner surface of a suction system reusable canister, for the collection of substances such as blood, bodily fluids, rinsing fluids, body tissue, or gas (e.g., laser plume evacuation) from a site of operation. The device may be soft-walled, or it may have walls of semi-rigid plastic with a dedicated lid. Together with the canister, it can be used singularly, or in a connected series to provide greater capacity. This device should be discarded, including its contaminated waste content, according to the environmental legislation by which the user is bound (e.g., incineration, recycling, landfill). This is a single-use device.

Regulatory Flags#

DUNS number
527142751
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970754496159Orthopaedic Suction SetAEEFS11112023-09-08
16970754496156Orthopaedic Suction SetAEEFS11112023-09-08
36970754494866Dynarex CorporationGC1957R082023-02-04
06970754494728GcmedicaGC0652DD2022-12-09
06970754494735GcmedicaGC0653DD2022-12-09
06970754494742GcmedicaGC0654DT2022-12-09
06970754496593NatusGC8022F011420020,Adult,52CM*2+32CM,Clear2022-12-09
06970754496609NatusGC8022F011420050,Adult,52CM*2+2.15M,Clear2022-12-09
06970754496616NatusGC8022F121420030,Pediatric,52CM*2+92CM,Clear2022-12-09
06970754496623NatusGC8022F031420040,Infant,52CM*2+92CM,Clear2022-12-09
06970754496777De Soutter MedicalGC1433C1U2022-12-09
06970754498467GcmedicaGC0654DD2022-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10198956417991CARDINAL HEALTHCardinal Health 200, LLCGCX2026-03-16
10198956375642CARDINAL HEALTHCardinal Health 200, LLCGCX2026-02-13
10198956277939CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-22
10198956289284CARDINAL HEALTHCardinal Health 200, LLCGCX2026-01-12
10198956261808CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-17
10192253043365CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043372CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043389CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043396CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043402CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10192253043419CARDINAL HEALTHCardinal Health 200, LLCGCX2025-12-16
10198956252127CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-25
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
10198956241909CARDINAL HEALTHCardinal Health 200, LLCGCX2025-11-04
10198956242098CARDINAL HEALTHCardinal Health 200, LLCGCX2025-10-22
10198956160859CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198956180383CARDINAL HEALTHCardinal Health 200, LLCGCX2025-08-27
10198459423567MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-21
10198459398063MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.GCX2025-07-07
10198956073883CARDINAL HEALTHCardinal Health 200, LLCGCX2025-07-04
10198956033252CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-12
10198956087279CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-11
10198956097728CARDINAL HEALTHCardinal Health 200, LLCGCX2025-06-05
10198956083790CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
10198956013704CARDINAL HEALTHCardinal Health 200, LLCGCX2025-05-09
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08