FDA.reportPublic FDA data

Dynarex Corporation

Primary DI
36970754494866
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
Rx
false
OTC
false
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
527142751
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
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
06970754496159Orthopaedic Suction SetAEEFS11112023-09-08
16970754496156Orthopaedic Suction SetAEEFS11112023-09-08
16970754494862Dynarex 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
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc CanisterDynarex CorporationGCX2026-09-25
10198956534681CARDINAL HEALTHCardinal Health 200, LLCGCX2026-07-27
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
08682952420093DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-11-06
00848530084011Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-06-18
00848530099640Tracheostomy and Suction AccessorySunset Healthcare Solutions, Inc.GCX2025-05-21
00848530103996Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-14
00848530104009Oxygen Wrench and Washer KitSunset Healthcare Solutions, Inc.GCX2025-05-14
00848530105464Washer with Rubber Ring - AluminumSunset Healthcare Solutions, Inc.GCX2025-05-14
08682952418014PergoPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-13
00848530105747Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105754Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105723Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
00848530105730Oxygen AccessorySunset Healthcare Solutions, Inc.GCX2025-05-12
08682952418144DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-08
08682952417437DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417451DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
08682952417482DeRoyalPERGO MEDIKAL VE ILAC SANAYI ANONIM SIRKETIGCX2025-05-07
10192253041736ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041743ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253041750ArgyleCardinal Health 200, LLCGCX2025-03-24
10192253038965ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038972ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038989ArgyleCardinal Health 200, LLCGCX2025-02-28
10192253038996ArgyleCardinal Health 200, LLCGCX2025-02-28